522 Postmarket Surveillance Studies Database

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font-size: 10px; font-weight: bold; } #pss-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #pss-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #pss-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #pss-results-table tr:nth-child(odd) { background-color: #f3f3f3; } .sort { float: right; margin-top: 5px;} .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } </style> <div class="pss-intro"> <div> The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device. <p><a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/522-postmarket-surveillance-studies" style="text-decoration:underline;">Learn more...</a></p> </div> <div id="pss-form"> <form method="post" action="pss.cfm"> <input id="pss-search" name="ud" type="text" onblur="if(this.value=='')this.value='Search';" onfocus="if(this.value=='Search')this.value='';" value="Search" /> <input style="vertical-align: ;" value="Search" type="submit" />        <input type="Button" value="Active Orders" style="background-color:#C3D69B" onclick=" location.href='/scripts/cdrh/cfdocs/cfpma/pss.cfm?s=a'">  <input type="Button" value="Inactive Orders" style="background-color:#E6B9B8" onclick=" location.href='/scripts/cdrh/cfdocs/cfpma/pss.cfm?s=c'">  <input type="Button" value="All Orders" style="background-color:#7F7F7F" onclick=" location.href='/scripts/cdrh/cfdocs/cfpma/pss.cfm?s=t'"> </form> </div> </div> <table width="100%" align="center" style="font-family: arial; color: #23238E;"> <tr valign="top"> <td width="20%"> </td> <td width="60%" nowrap style="font-size:9pt;"> To search for Manufacturer beginning with a specific letter, select that letter<br> <div align="center"> <TABLE CELLPADDING="3" CELLSPACING="0" align="center" width="20%"> <TR> <td> </td> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=A#A" title="" style="text-decoration: none; color: black">A</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=B#B" title="" style="text-decoration: none; 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color: black">O</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=P#P" title="" style="text-decoration: none; color: black">P</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=R#R" title="" style="text-decoration: none; color: black">R</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=S#S" title="" style="text-decoration: none; color: black">S</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=T#T" title="" style="text-decoration: none; color: black">T</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=U#U" title="" style="text-decoration: none; color: black">U</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=V#V" title="" style="text-decoration: none; color: black">V</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=W#W" title="" style="text-decoration: none; color: black">W</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=X#X" title="" style="text-decoration: none; color: black">X</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <TD valign="middle"><TABLE BORDER="0" CELLPADDING="1" CELLSPACING="0"> <TR valign="middle"><TD BGCOLOR="#23238E"> <table BORDER="0" CELLPADDING="0" CELLSPACING="0" bgcolor="#e9e9e3"> <tr> <td BGCOLOR="#e9e9e3" align="center" valign="middle" width="10">  <A Href="pss.cfm?start_search=Z#Z" title="" style="text-decoration: none; color: black">Z</a>  </td> </tr> </table> </TD></TR> <TR valign="middle"><TD BGCOLOR="#23238E"></TD></TR> </TABLE> </TD> <td> </td> </TR> </TABLE> </div> </td> <td width="20%"> </td> </tr> <tr valign="top"> <td> </td> <td align="center" style="font-family: arial; color: #23238E; font-size: 9pt;"> <B>330</B> orders </td> <td> </td> </tr> </table> <table border="0" cellpadding="0" cellspacing="0" align="center" style="font-family: arial; color: #23238E;" width="100%"> <tr valign="top"> <td bgcolor="#888888"> <table border="0" cellpadding="5" cellspacing="1" width="100%" style="font-family: arial; color: #23238E;"> <tr valign="top"> <td bgcolor="#e9e9e3" colspan="7"> <table cellpadding=0 cellspacing=0 border=0 width="100%" style="font-family: arial; color: #23238E; font-size: 9pt;> <tr bgcolor="" > <td bgcolor="#E6B9B8" align="left">  Inactive Orders</td> <td align="right" width="40%" > <table width="100%" style="font-family: arial; color: #23238E; font-size: 9pt;> <tr valign="top"> <td align="right" width="40%" > <table width="100%" style="font-family: arial; color: #23238E; font-size: 9pt;"> <tr valign="top"><td align="right"><form name="subpssform" action="pss_Excel.cfm" method="post" id="pssform" autocomplete="off"><input type="hidden" name="ID" value="187%2C161%2C162%2C163%2C164%2C165%2C342%2C344%2C7%2C18%2C188%2C189%2C191%2C193%2C194%2C195%2C196%2C197%2C198%2C199%2C200%2C201%2C276%2C277%2C278%2C309%2C315%2C316%2C317%2C335%2C166%2C167%2C26%2C8%2C347%2C190%2C192%2C275%2C359%2C30%2C348%2C341%2C31%2C32%2C35%2C42%2C43%2C44%2C45%2C46%2C47%2C48%2C49%2C50%2C51%2C52%2C53%2C54%2C55%2C56%2C57%2C58%2C59%2C60%2C61%2C62%2C63%2C41%2C10%2C267%2C207%2C208%2C209%2C210%2C279%2C299%2C300%2C318%2C319%2C320%2C343%2C168%2C213%2C214%2C215%2C216%2C217%2C280%2C336%2C218%2C219%2C220%2C288%2C321%2C322%2C323%2C324%2C325%2C5%2C33%2C34%2C36%2C37%2C221%2C222%2C223%2C224%2C241%2C242%2C282%2C283%2C284%2C310%2C328%2C337%2C292%2C225%2C295%2C339%2C303%2C226%2C257%2C258%2C261%2C262%2C326%2C327%2C227%2C228%2C238%2C186%2C11%2C313%2C66%2C169%2C170%2C234%2C235%2C236%2C237%2C67%2C68%2C69%2C70%2C71%2C72%2C73%2C171%2C229%2C230%2C231%2C232%2C281%2C21%2C353%2C363%2C351%2C12%2C13%2C340%2C239%2C290%2C291%2C311%2C346%2C286%2C287%2C27%2C28%2C29%2C172%2C173%2C289%2C74%2C75%2C76%2C77%2C78%2C79%2C80%2C81%2C82%2C83%2C84%2C85%2C86%2C87%2C88%2C89%2C90%2C91%2C92%2C174%2C175%2C156%2C157%2C176%2C14%2C15%2C1%2C107%2C108%2C109%2C110%2C111%2C112%2C113%2C114%2C115%2C116%2C117%2C118%2C119%2C120%2C121%2C122%2C123%2C124%2C125%2C126%2C127%2C128%2C185%2C308%2C25%2C243%2C39%2C371%2C354%2C244%2C245%2C246%2C329%2C330%2C177%2C160%2C178%2C179%2C377%2C17%2C358%2C355%2C364%2C365%2C233%2C3%2C352%2C314%2C252%2C285%2C331%2C332%2C253%2C306%2C254%2C334%2C255%2C256%2C248%2C247%2C259%2C260%2C298%2C345%2C211%2C212%2C297%2C181%2C249%2C250%2C203%2C251%2C263%2C264%2C202%2C204%2C205%2C206%2C16%2C6%2C368%2C378%2C182%2C266%2C268%2C265%2C293%2C294%2C333%2C4%2C183%2C184%2C19%2C20%2C38%2C269%2C270%2C271%2C272%2C158%2C159%2C307%2C273%2C274%2C129%2C130%2C131%2C133%2C134%2C135%2C137%2C138%2C139%2C142%2C143%2C144%2C145%2C146%2C147%2C148%2C149%2C150%2C151%2C152%2C153%2C154%2C155%2C22%2C23%2C2" /> <input type="hidden" name="sortcolumn" value="an" /><input type="hidden" name="s" value="" /><a href="mailto:MandatedStudiesPrograms@fda.hhs.gov">Suggest Enhancement / Report Issue</a> | <img src="/scripts/cdrh/cfdocs/images/excel.gif" border="0" alt="export reports to excel"><a title="Export to Excel" href="javascript: document.getElementById('pssform').submit();">Export to Excel</a></form></td></tr></table> </td> </tr> </table> </td> </tr> </table> </td> </TR> <tr bgcolor="#f9f9f3" style="font-family: arial; color: #23238E;"> <td align="center" width="50px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr> <td> <A href="./pss.cfm?sb=pdn&s=a"><img src="../search/arrow.up.gif" border="0" height="20" width="20" alt="Sort By 522 Order Number"></A> </td> <th>522<br>Order<br>Number</th> <td> <A href="./pss.cfm?sb=pdnd&s=a"><img src="../search/arrow.down.gif" border="0" height="20" width="20" alt="Sort By 522 Order Number -- Descending"></A> </td> </tr> </table> </td> <td align="center" width="80px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr><td> <A href="./pss.cfm?sb=an&s=a"><img src="../search/arrow.up.gif" border="0" height="20" width="20" alt="Sort By Manufacturer"></A> </td> <th>Manufacturer</th> <td> <A href="./pss.cfm?sb=and&s=a"><img src="../search/arrow.down.gif" border="0" height="20" width="20" alt="Sort By Manufacturer -- Descending"></A> </td></tr> </table> </td> <td align="center" width="250px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0" width="100%"> <tr><td>   <A href="./pss.cfm?sb=dtn&s=a"><img src="../search/arrow.up.gif" border="0" height="20" width="20" alt="Sort By Device Name"></A> </td> <th>Device<br>Name</th> <td> <A href="./pss.cfm?sb=dtnd&s=a"><img src="../search/arrow.down.gif" border="0" height="20" width="20" alt="Sort By Device Name -- Descending"></A> </td></tr> </table> </td> <td align="center" width="80px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr><td> <A href="./pss.cfm?sb=ms&s=a"><img src="../search/arrow.up.gif" border="0" height="20" width="20" alt="Sort By Medical Specialty"></A> </td> <th>Medical<br>Specialty</th> <td> <A href="./pss.cfm?sb=msd&s=a"><img src="../search/arrow.down.gif" border="0" height="20" width="20" alt="Sort By Medical Specialty -- Descending"></A> </td></tr> </table> </td> <td align="center" width="80px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr><td> <A href="./pss.cfm?sb=da&s=a"><img src="../search/arrow.up.gif" border="0" height="20" width="20" alt="Sort By Date 522 Order"></A> </td> <th>Date 522<br>Order</th> <td> <A href="./pss.cfm?sb=dad&s=a"><img src="../search/arrow.down.gif" border="0" height="20" width="20" alt="Sort By Date 522 Order -- Descending"></A> </td></tr> </table> </td> <td align="center" width="80px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr><th>Study<br>Name</th></tr> </table> </td> <td align="center" width="60px"> <table style="font-family: arial; color: #23238E; font-size: 9pt;" cellpadding="0" cellspacing="0"> <tr><th>Study Status</th></tr> </table> </td> </tr> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Acell, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Acell matristem pelvic floor matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=187&c_id=592" name="A" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110124</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Advanced Bioresearch Association</td> <td style="font-size: 8pt;" ROWSPAN="1">Natural lock acetabular component</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=161&c_id=526" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110125</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Advanced Bioresearch Association</td> <td style="font-size: 8pt;" ROWSPAN="1">Muller titanium backed acetabular cup component</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=162&c_id=527" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110126</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Advanced Bioresearch Association</td> <td style="font-size: 8pt;" ROWSPAN="1">Pm cementless screw-in acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=163&c_id=528" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110127</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Advanced Bioresearch Association</td> <td style="font-size: 8pt;" ROWSPAN="1">Weill cementless threaded acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=164&c_id=529" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110128</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Advanced Bioresearch Association</td> <td style="font-size: 8pt;" ROWSPAN="1">Freeman acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=165&c_id=530" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130043</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Aesculap, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ring upm total hip replacement</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/29/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=342&c_id=873" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130045</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Aesculap, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Modular range of ring pros. For hip replacement</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/29/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=344&c_id=872" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS090002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Alphatec Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Zodiac dynamo semi-rigid spinal system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=7&c_id=310" name="A" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS090012</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Alphatec Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Isobar semi-rigid spinal system & dual dampener</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=18&c_id=320" name="A" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams large pore polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=188&c_id=593" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams large pore polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=189&c_id=594" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120005</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams elevate anterior & apical prolapse repair system with intepro lite</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=191&c_id=596" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120007</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=193&c_id=598" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=194&c_id=599" name="A" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120009</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=195&c_id=600" name="A" title="Reporting Schedule Details">Apogee and Perigee System w/IntePro Lite</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="A">PS120010</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix</td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=196&c_id=601" name="A" title="Reporting Schedule Details">Apogee AE and Eff Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=196&c_id=717" name="A" title="Reporting Schedule Details">Perigee AE and Eff Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120011</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=197&c_id=602" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120012</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=198&c_id=603" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120013</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Apogee and perigee systems with pc coated intepro lite</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=199&c_id=604" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120014</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=200&c_id=605" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120015</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=201&c_id=606" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120090</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Miniarc precise single-incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=276&c_id=681" name="A" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120091</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Miniarc precise single-incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=277&c_id=682" name="A" title="Reporting Schedule Details">SUI AE and Effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120092</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Miniarc precise single-incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=278&c_id=683" name="A" title="Reporting Schedule Details">SUI AE and Effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130011</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Elevate prolapse repair systems </td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=309&c_id=826" name="A" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130017</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams triangle silicone-coated sling and surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=315&c_id=832" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130018</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Topas system</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=316&c_id=833" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130019</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Pfr sling system, (part of the pelvic floor repair system)</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=317&c_id=834" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS130037</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Medical Systems, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Miniarc pro single-incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=335&c_id=852" name="A" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110129</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Ortomed Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">Titanium mittelmeier type acetabular</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=166&c_id=531" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS110130</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">American Ortomed Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">Uniloc-cementless & self tap acetabular</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=167&c_id=532" name="A" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS100002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Amsino International, Inc</td> <td style="font-size: 8pt;" ROWSPAN="1">Cortez needle free iv connector</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=26&c_id=363" name="A" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS090003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Applied Spine Technologies, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Bar pedicle screw spinal fixation system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=8&c_id=311" name="A" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS140001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Argo Medical Technologies, Inc</td> <td style="font-size: 8pt;" ROWSPAN="1">Rewalk</td> <td style="font-size: 8pt;" ROWSPAN="1">Neurology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/26/2014</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=347&c_id=6429" name="A" title="Reporting Schedule Details">ReWalk RWE Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120004</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Astora Womens Health</td> <td style="font-size: 8pt;" ROWSPAN="1">Ams elevate anterior & apical prolapse repair system with intepro llite</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=190&c_id=595" name="A" title="Reporting Schedule Details">POP AE and effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="A">PS120006</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Astora Womens Health</td> <td style="font-size: 8pt;" ROWSPAN="2">Ams elevate apical and posterior prolapse repair system with intepro lite </td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=192&c_id=597" name="A" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=192&c_id=715" name="A" title="Reporting Schedule Details">Elevate System w/InteXen LP</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS120089</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Astora Womens Health</td> <td style="font-size: 8pt;" ROWSPAN="1">Miniarc precise single-incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=275&c_id=680" name="A" title="Reporting Schedule Details">SUI AE and Effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="A">PS180001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Avenu Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ellipsys vascular access system </td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/21/2018</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=359&c_id=4836" name="A" title="Reporting Schedule Details">Postmarket Study</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS100006</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">B. Braun Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ultrasite valve</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=30&c_id=367" name="B" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS140002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Bard Peripheral Perivascular</td> <td style="font-size: 8pt;" ROWSPAN="1">Simon Nitinol System</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/17/2014</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=348&c_id=3018" name="B" title="Reporting Schedule Details">Simon Nitinol PS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130042</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Baxter Healthcare Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Vena Cava Filter</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/29/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=341&c_id=870" name="B" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS100007</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Baxter Healthcare Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Iv/catheter extension set with nac plus needleless access connector and nac plus needleless access connector</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=31&c_id=368" name="B" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS100008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Becton Dickinson Infusion Therapy Systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Bd posiflow/tm positive displacement valve</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=32&c_id=369" name="B" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS100011</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Becton Dickinson Infusion Therapy Systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Nima needleless injectionsite master adapter with posiflow positive displacement feature, and iv sets</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=35&c_id=372" name="B" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="B">PS110005</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one-piece modular heads</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=42&c_id=406" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=42&c_id=2361" name="B" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110006</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a magnum 12/14 taper inserts and one-piece modular heads</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=43&c_id=407" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110007</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Lateralized taperloc microplasty femoral components</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=44&c_id=408" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a-magnum tri-spike acetabular component</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=45&c_id=409" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110009</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Altra press-fit hip system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=46&c_id=410" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110010</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Altra fx hip system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=47&c_id=411" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110011</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Echo bi-metric press-fit stems</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=48&c_id=412" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110012</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Parallel-sided extensively coated femoral stems</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=49&c_id=413" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110013</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Compress segmental femoral replacement system (short spindle and anchor plug)</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=50&c_id=415" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110014</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Metal on metal acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=51&c_id=416" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110015</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a 28mm ringloc liner</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=52&c_id=417" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110016</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=53&c_id=418" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110017</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a magnum system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=54&c_id=419" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110018</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Mallory-head modular calcar stems with interlocking slots</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=55&c_id=420" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110019</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">M2a/c2a acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=56&c_id=421" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110020</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Porous coated acetabular components</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=57&c_id=422" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110021</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Compress segmental femoral replacement system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=58&c_id=423" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110022</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet metal-on-metal hip systems- expanded contraindications</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=59&c_id=424" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110023</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet modular femoral revision system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=60&c_id=425" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110024</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Balance hip system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=61&c_id=426" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110025</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Taper 2 porous femoral stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=62&c_id=427" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS110026</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biomet Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ringloc + hybrid acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=63&c_id=428" name="B" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="B">PS110004</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Biomet Microfixation</td> <td style="font-size: 8pt;" ROWSPAN="2">Total temporomandibular joint replacement system</td> <td style="font-size: 8pt;" ROWSPAN="2">Dental</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">02/04/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=41&c_id=394" name="B" title="Reporting Schedule Details">Time to Revision</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=41&c_id=400" name="B" title="Reporting Schedule Details">Explant</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS090004</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Biospine Co., Ltd.</td> <td style="font-size: 8pt;" ROWSPAN="1">Bioflex® </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=10&c_id=312" name="B" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS120081</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific</td> <td style="font-size: 8pt;" ROWSPAN="1">Xenform soft tissue repair matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=267&c_id=772" name="B" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="4" align="center"> <A name="B">PS120021</A> </td> <td style="font-size: 8pt;" ROWSPAN="4">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="4">Lite pelvic floor repair kits</td> <td style="font-size: 8pt;" ROWSPAN="4">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="4">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=207&c_id=612" name="B" title="Reporting Schedule Details">AE and effectiveness rates for Uphold LITE</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=207&c_id=750" name="B" title="Reporting Schedule Details">DUET LITE</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=207&c_id=797" name="B" title="Reporting Schedule Details">Posterior LITE</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=207&c_id=798" name="B" title="Reporting Schedule Details">Anterior LITE</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS120022</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Pelvic floor repair system (pinnacle duet)</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=208&c_id=613" name="B" title="Reporting Schedule Details">AE and effectiveness rates-Duet</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS120023</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Pinnacle pelvic floor repair kit ii (uphold)</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=209&c_id=614" name="B" title="Reporting Schedule Details">AE and effectiveness rates-Uphold</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="B">PS120024</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="2">Pinnacle pelvic floor repair kits (pinnacle)</td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=210&c_id=615" name="B" title="Reporting Schedule Details">AE and effectiveness rates-Anterior</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=210&c_id=755" name="B" title="Reporting Schedule Details">Posterior</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS120093</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Solyx Single Incision Sling System</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=279&c_id=684" name="B" title="Reporting Schedule Details">SUI AE and Effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Greenfield vena cava filters</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">02/28/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=299&c_id=808" name="B" title="Reporting Schedule Details">Greenfield PS study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Vena cava filters</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">02/28/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=300&c_id=809" name="B" title="Reporting Schedule Details">Greenfield PS study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130020</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Surgical fabrics</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=318&c_id=835" name="B" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130021</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Modification to trelex mesh surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=319&c_id=836" name="B" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="B">PS130022</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Modification to Surgical Mesh Polymeric</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=320&c_id=837" name="B" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="B">PS130044</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Boston Scientific Corporation</td> <td style="font-size: 8pt;" ROWSPAN="2">Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold</td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">07/03/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=343&c_id=959" name="B" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=343&c_id=2220" name="B" title="Reporting Schedule Details">Posterior Lite</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS110131</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">CONTOUR II LINK SP TOTAL HIP PROSTHESIS</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=168&c_id=533" name="C" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120027</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=213&c_id=618" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120028</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=214&c_id=619" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120029</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=215&c_id=620" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120030</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Bard prolapse repair system</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=216&c_id=621" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120031</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Bard pelvisoft acellular collagen biomesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=217&c_id=622" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120094</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ajust adjustable single incision sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=280&c_id=685" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130038</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">C.R. Bard Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ajust helical adjustable single-incision sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=336&c_id=853" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120032</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Popmesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=218&c_id=623" name="C" title="Reporting Schedule Details">AE and effectiveness rates-PoP Mesh</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120033</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ascend blue ac mesh; Ascend blue pc mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=219&c_id=624" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120034</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ascend blue ac mesh; Ascend blue pc mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=220&c_id=625" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120102</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Desara mini</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=288&c_id=736" name="C" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130023</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">T-sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=321&c_id=838" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130024</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=322&c_id=839" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130025</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Desara mesh sling, model cal-dsol</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=323&c_id=840" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130026</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Desara mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=324&c_id=841" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130027</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Caldera Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Desara mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=325&c_id=842" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS060003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cardica, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">C-port distal anastomosis system</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/14/2006</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=5&c_id=275" name="C" title="Reporting Schedule Details">Graft Patency and Technical Failure</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS100009</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CareFusion</td> <td style="font-size: 8pt;" ROWSPAN="1">Maxplus tru-swab positive displacement connector</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=33&c_id=370" name="C" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS100010</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CareFusion</td> <td style="font-size: 8pt;" ROWSPAN="1">Maxplus tru-swab positive displacement connector</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=34&c_id=371" name="C" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS100012</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CareFusion</td> <td style="font-size: 8pt;" ROWSPAN="1">Ivac needle free administration sets</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=36&c_id=373" name="C" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS100013</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CareFusion</td> <td style="font-size: 8pt;" ROWSPAN="1">Smartsite needle free valve administration sets</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=37&c_id=374" name="C" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120035</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Exair anterior and posterior prolapse repair systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=221&c_id=626" name="C" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120036</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Exair anterior and posterior prolapse repair systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=222&c_id=627" name="C" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120037</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Mentor novasilk mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=223&c_id=628" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="C">PS120038</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="2">Restorelle polypropylene mesh; Restorelle polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="2">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=224&c_id=629" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=224&c_id=763" name="C" title="Reporting Schedule Details">Restorelle P, EZA, EZP, and L models</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="C">PS120055</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="2">Minimesh polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=241&c_id=646" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=241&c_id=775" name="C" title="Reporting Schedule Details">Restorelle P, EZA and L model</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="C">PS120056</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="2">Minimesh polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=242&c_id=647" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=242&c_id=774" name="C" title="Reporting Schedule Details">Restorelle P, EZA and L models</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120096</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Gyne ideas minitape rp device</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=282&c_id=687" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120097</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Minitape urethral sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=283&c_id=688" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120098</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Minitape urethral sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=284&c_id=689" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130012</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Mentor suspend sling</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=310&c_id=827" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130030</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Mentor suspend sling</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=328&c_id=845" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130039</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Coloplast Corp</td> <td style="font-size: 8pt;" ROWSPAN="1">Altis single incision sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=337&c_id=854" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="C">PS120106</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Coloplast Corp.</td> <td style="font-size: 8pt;" ROWSPAN="2">Restorelle polypropylene mesh</td> <td style="font-size: 8pt;" ROWSPAN="2">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=292&c_id=739" name="C" title="Reporting Schedule Details">POP AE and Effectiveness rates, registry</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=292&c_id=764" name="C" title="Reporting Schedule Details">Restorelle P, EZA, EZP, and L models</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120039</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cook Biotech Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Surgisis staple line reinforcement</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=225&c_id=630" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="C">PS120109</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Cook Biotech Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Surgisis sling</td> <td style="font-size: 8pt;" ROWSPAN="2">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=295&c_id=742" name="C" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=295&c_id=874" name="C" title="Reporting Schedule Details">J-PF-POST, J-SLH, J-PFV, J-PF and J-PF-ANT models</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130040</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cook Biotech Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/17/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=339&c_id=863" name="C" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130005</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cook Incorporated</td> <td style="font-size: 8pt;" ROWSPAN="1">Vena Cava Filter</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">02/28/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=303&c_id=812" name="C" title="Reporting Schedule Details">Celect IVC Filter</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120040</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cousin Biotech SARL</td> <td style="font-size: 8pt;" ROWSPAN="1">Biotech SAS for Biomesh® Pl and Biomesh® Plug and Patch</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=226&c_id=631" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120071</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Parietene duo and quadra polypropylene meshes</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=257&c_id=662" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120072</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Ugytex dual knit mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=258&c_id=663" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120075</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=261&c_id=666" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120076</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=262&c_id=667" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130028</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Ivs tunneller</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=326&c_id=843" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS130029</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Covidien</td> <td style="font-size: 8pt;" ROWSPAN="1">Ivs tunneller devices </td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=327&c_id=844" name="C" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120041</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CryoLife, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Propatch soft tissue repair matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=227&c_id=632" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120042</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">CryoLife, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Propatch soft tissue repair matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=228&c_id=633" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="C">PS120052</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Cytori Therapeutics, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Macropore surgiwrap (ts)</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=238&c_id=643" name="C" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS110149</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Depuy Orthopaedics, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Depuy corail hip system, revision stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=186&c_id=554" name="D" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS090005</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DePuy Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">6.35mm and 5.5mm peek rods </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=11&c_id=313" name="D" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS130015</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DIMA</td> <td style="font-size: 8pt;" ROWSPAN="1">Contasure Needleless sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=313&c_id=830" name="D" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="D">PS110029</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">DJO Global</td> <td style="font-size: 8pt;" ROWSPAN="2">Encore clp offset total hip system, metal/metal hip system,fmp metal/metal acetabular insert, revelation stem,djo surgical revision femoral i-lip system, metal backed acetabular component, </td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=66&c_id=431" name="D" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=66&c_id=818" name="D" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS110132</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Downs Surgical Ltd.</td> <td style="font-size: 8pt;" ROWSPAN="1">RING UPM TOTAL HIP REPLACEMENT</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=169&c_id=534" name="D" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS110133</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Downs Surgical Ltd.</td> <td style="font-size: 8pt;" ROWSPAN="1">MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=170&c_id=535" name="D" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS120048</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DSM Biomedical</td> <td style="font-size: 8pt;" ROWSPAN="1">Bioblanket surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=234&c_id=639" name="D" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS120049</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DSM Biomedical</td> <td style="font-size: 8pt;" ROWSPAN="1">Bioblanket surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=235&c_id=640" name="D" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS120050</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DSM Biomedical</td> <td style="font-size: 8pt;" ROWSPAN="1">Medeor matrix models 30010-xx (hydrated); 30020-xx (dry)</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=236&c_id=641" name="D" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="D">PS120051</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">DSM Biomedical</td> <td style="font-size: 8pt;" ROWSPAN="1">Kensey nash ecm surgical patch</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=237&c_id=642" name="D" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110030</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Metal/metal hip system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=67&c_id=432" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=67&c_id=819" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110031</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Modification to: Fmp metal/metal acetabular insert, models 499-28, 499-34, 499-38</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=68&c_id=433" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=68&c_id=820" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110032</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Fmp metal/metal acetabular insert, 499-28,449-34, 499-38</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=69&c_id=434" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=69&c_id=821" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110033</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Revelation stem, model 427-21/42-080/180</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=70&c_id=435" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=70&c_id=822" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110034</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Djo surgical revision femoral hip system, model 428-14/24-140/200; 428-00-050/110</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=71&c_id=436" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=71&c_id=823" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110035</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Metal backed acetabular component</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=72&c_id=437" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=72&c_id=824" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="E">PS110036</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Encore Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Fmp metal/metal acetabular insert</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=73&c_id=438" name="E" title="Reporting Schedule Details">Clinical Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=73&c_id=825" name="E" title="Reporting Schedule Details">Device Retrieval Study</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS110134</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Endomedics, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">SELF-ALIGNING ACETABULAR COMPONENT</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=171&c_id=536" name="E" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS120043</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ethicon, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Gynecare prolift +m* pelvic floor repair systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=229&c_id=634" name="E" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS120044</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ethicon, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Gynecare prosima pelvic floor repair systems</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=230&c_id=635" name="E" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS120045</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ethicon, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tbd ethicon mesh (gynecare gynemesh m)</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=231&c_id=636" name="E" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS120046</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ethicon, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=232&c_id=637" name="E" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS120095</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ethicon, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Gynecare tvt secur system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=281&c_id=686" name="E" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="E">PS090015</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Exactech, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Modified vertiflex spinal screw system (with dynabolt rods)</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=21&c_id=323" name="E" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="F">PS150002</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Fujifilm Medical Systems USA, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Fujifilm duodenoscopes</td> <td style="font-size: 8pt;" ROWSPAN="2">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">10/05/2015</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=353&c_id=3691" name="F" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=353&c_id=3725" name="F" title="Reporting Schedule Details">Sampling and Culturing Study</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="F">PS190002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">FUJIFILM Medical Systems, U.S.A., Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Duodenoscope</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/28/2019</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=363&c_id=5618" name="F" title="Reporting Schedule Details">Sampling and Culturing</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="G">PS140004</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Genzyme Sanofi</td> <td style="font-size: 8pt;" ROWSPAN="1">GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">12/11/2014</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=351&c_id=3148" name="G" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="G">PS090006</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Globus Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Protex rods</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=12&c_id=314" name="G" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="G">PS090007</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Globus Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Transition stabilization system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=13&c_id=315" name="G" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="H">PS130041</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Halt Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Acessa system </td> <td style="font-size: 8pt;" ROWSPAN="2">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">06/17/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=340&c_id=864" name="H" title="Reporting Schedule Details">Newly Enrolled</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=340&c_id=1805" name="H" title="Reporting Schedule Details">(IDE) Long Term Follow-up</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="H">PS120053</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Herniamesh SRL</td> <td style="font-size: 8pt;" ROWSPAN="1">Pelvimesh / hermesh 7</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=239&c_id=644" name="H" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="H">PS120104</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Herniamesh SRL</td> <td style="font-size: 8pt;" ROWSPAN="1">Biosling Bioabsorbable Polymer Sling & Surgical Mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=290&c_id=737" name="H" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="H">PS120105</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Herniamesh SRL</td> <td style="font-size: 8pt;" ROWSPAN="1">T-sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=291&c_id=738" name="H" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="H">PS130013</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Herniamesh SRL</td> <td style="font-size: 8pt;" ROWSPAN="1">Hemiamesh t-sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=311&c_id=828" name="H" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="H">PS130047</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Herniamesh SRL</td> <td style="font-size: 8pt;" ROWSPAN="1">T-Sling</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">09/26/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=346&c_id=1555" name="H" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS120100</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">IBI Israel Biomedical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">EndoFast Reliant¿.</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=286&c_id=734" name="I" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS120101</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">IBI Israel Biomedical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">Endofast reliant¿.</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=287&c_id=735" name="I" title="Reporting Schedule Details">AE & Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS100003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">ICU Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Clc2000</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=27&c_id=364" name="I" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS100004</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">ICU Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Clc2000 catheter patency device</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=28&c_id=365" name="I" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS100005</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">ICU Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tego</td> <td style="font-size: 8pt;" ROWSPAN="1">General Hospital</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">07/21/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=29&c_id=366" name="I" title="Reporting Schedule Details">BSI rate</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS110135</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Implantology LLC</td> <td style="font-size: 8pt;" ROWSPAN="1">Cps acetabular component</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=172&c_id=537" name="I" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS110136</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Implantology LLC</td> <td style="font-size: 8pt;" ROWSPAN="1">Fpc/sfpc/rfpc acetabular component</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=173&c_id=538" name="I" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="I">PS120103</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Injectx, Inc</td> <td style="font-size: 8pt;" ROWSPAN="1">Biosling bioabsorbable polymer sling & surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=289&c_id=745" name="I" title="Reporting Schedule Details">Postmarket Surveillance Study</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="J">PS110037</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="1">ULTIMA METAL-ON-METAL ACETABULAR CUP</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=74&c_id=439" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110038</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle metal-on-metal acetabular cup liners</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=75&c_id=440" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=75&c_id=692" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110039</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Pinnacle metal-on-metal acetabular cup liners</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=76&c_id=441" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=76&c_id=693" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110040</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle metal-on-metal acetabular cup liner</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=77&c_id=442" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=77&c_id=694" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110041</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy asr modular acetabular cup system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=78&c_id=443" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=78&c_id=695" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110042</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Corail amt hip prosthesis</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=79&c_id=444" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=79&c_id=696" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110043</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Dupuy s-rom std hip stem prosthesis</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=80&c_id=445" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=80&c_id=698" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110044</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle metal-on-metal acetabular cup liners</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=81&c_id=446" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=81&c_id=699" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110045</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy asr taper sleeve adapter</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=82&c_id=447" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=82&c_id=700" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110046</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy corail amt dysplasia hip prosthesis</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=83&c_id=448" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=83&c_id=701" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110047</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy tri-lock bone preservation stem</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=84&c_id=449" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=84&c_id=702" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110048</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy asr xl modular acetabular cup system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=85&c_id=450" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=85&c_id=703" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110049</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy asr 300 acetabular cup system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=86&c_id=451" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=86&c_id=704" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110050</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy asphere m-spec head</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=87&c_id=452" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=87&c_id=705" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110051</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy c-stem amt</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=88&c_id=453" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=88&c_id=706" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110052</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle metal-on-metal acetabular cup liners</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=89&c_id=454" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=89&c_id=707" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110053</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle 100 with gription acetabular cups</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=90&c_id=455" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=90&c_id=708" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="J">PS110054</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="2">Depuy pinnacle with gription acetabular cups</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=91&c_id=456" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=91&c_id=709" name="J" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="J">PS110055</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Johnson and Johnson</td> <td style="font-size: 8pt;" ROWSPAN="1">PROFILE FEMORAL HIP</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=92&c_id=457" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="J">PS110137</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Joint Medical Products Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=174&c_id=539" name="J" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="J">PS110138</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Joint Medical Products Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=175&c_id=551" name="J" title="Reporting Schedule Details">Metal Ion Levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="L">PS110119</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Link America, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Lidgrer-lund acetabular sockets</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=156&c_id=521" name="L" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="L">PS110120</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Link America, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Link metal-backed acetabular cups</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=157&c_id=522" name="L" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110139</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Med-Tek Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">H.N. Metal backed acetabular cup, noncemented</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=176&c_id=567" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS090008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Medtronic</td> <td style="font-size: 8pt;" ROWSPAN="1">Cd horizon® peek rods </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=14&c_id=316" name="M" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS090009</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Medtronic Sofamor Danek</td> <td style="font-size: 8pt;" ROWSPAN="1">Cd horizon® agile¿ dynamic stabilization device</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=15&c_id=317" name="M" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS010001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Medtronic Vascular</td> <td style="font-size: 8pt;" ROWSPAN="1">Aneurx stent graft system</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/13/2001</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=1&c_id=271" name="M" title="Reporting Schedule Details">AneuRx Stent Graft System</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="M">PS110070</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="2">Metal transcend articulation system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=107&c_id=4238" name="M" title="Reporting Schedule Details">Metal Ion Levels Microport</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=107&c_id=4239" name="M" title="Reporting Schedule Details">Explant</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110071</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Metal transcend articulation system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=108&c_id=473" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110072</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Metal transcend articulation system (larger sizes)</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=109&c_id=474" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110073</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve plus spiked acetabular shells and conserve total 56mm femoral head</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=110&c_id=475" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110074</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur s hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=111&c_id=476" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110075</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve plus revision shell and conserve plus thick shell</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=112&c_id=477" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110076</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur tapered hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=113&c_id=478" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110077</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Procotyl-e acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=114&c_id=479" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110078</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Lineage ha acetabular shells</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=115&c_id=480" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110079</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve plus ha acetabular shells</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=116&c_id=481" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110080</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur renaissance hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=117&c_id=482" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110081</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve total femoral head</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=118&c_id=483" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110082</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur xtr hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=119&c_id=484" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110083</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur lx hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=120&c_id=485" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110084</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve plus quadrafix acetabular shell</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=121&c_id=486" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110085</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur tl hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=122&c_id=487" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110086</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Dynasty acetabular shell and cocr acetabular liner</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=123&c_id=488" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110087</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Dynasty acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=124&c_id=489" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110088</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur lx revision 5/8 coated hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=125&c_id=490" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110089</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur lx 5/8 coated hip stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=126&c_id=491" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110090</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Dynasty porous acetabular shell, dynasty polyethylene acetabular liner, dynasty metal acetabular liner</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=127&c_id=492" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110091</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Profemur hip system modular necks</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=128&c_id=493" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS110148</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Conserve bio foam shell</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=185&c_id=575" name="M" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="M">PS130010</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">MicroPort</td> <td style="font-size: 8pt;" ROWSPAN="1">Link metal-backed acetabular cups</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/20/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=308&c_id=817" name="M" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="M">PS100001</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">MicroVention, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="2">Microvention hydrocoil-soft-frame</td> <td style="font-size: 8pt;" ROWSPAN="2">Neurology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">04/15/2010</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=25&c_id=340" name="M" title="Reporting Schedule Details">HydroCoil Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=25&c_id=796" name="M" title="Reporting Schedule Details">HydroSoft/HydroFrame Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="N">PS120057</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Neomedic International</td> <td style="font-size: 8pt;" ROWSPAN="1">SURELIFT PROLAPSE SYSTEM</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=243&c_id=648" name="N" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="N">PS110002</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Nexus CMF</td> <td style="font-size: 8pt;" ROWSPAN="2">Tmj fossa-eminence/condylar prosthesis system</td> <td style="font-size: 8pt;" ROWSPAN="2">Dental</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">02/04/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=39&c_id=565" name="N" title="Reporting Schedule Details">TMJ Fossa-Eminence and Condylar Pros</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=39&c_id=876" name="N" title="Reporting Schedule Details">TMJ Registry Study - Total</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS200002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Olympus America, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Evis exera iii duodenovideoscope tjf-q190v</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/17/2020</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=371&c_id=5902" name="O" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="O">PS150003</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Olympus Medical Systems Corporation (OMSC.</td> <td style="font-size: 8pt;" ROWSPAN="2">Duodenoscopes</td> <td style="font-size: 8pt;" ROWSPAN="2">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">10/05/2015</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=354&c_id=3692" name="O" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=354&c_id=3726" name="O" title="Reporting Schedule Details">Sampling and Culturing Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS120058</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Organogenesis, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">FORTAFLEX SURGICAL MESH</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=244&c_id=649" name="O" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS120059</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Organogenesis, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">FORTAFLEX SURGICAL MESH</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=245&c_id=650" name="O" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS120060</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Organogenesis, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">FORTAFLEX SURGICAL MESH</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=246&c_id=651" name="O" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS130031</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Organogenesis, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Fortaflex surgical sling</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=329&c_id=846" name="O" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS130032</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Organogenesis, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">FortaPerm surgical sling</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=330&c_id=847" name="O" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS110140</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopaedic Device Corp.</td> <td style="font-size: 8pt;" ROWSPAN="1">P.T.H. METAL-BACKED ACETABULAR CUP</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=177&c_id=550" name="O" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS110123</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic Manufacturing Co.</td> <td style="font-size: 8pt;" ROWSPAN="1">Ace 100 degrees tubular plate</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=160&c_id=525" name="O" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS110141</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Osteotechnology, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Biometric screw fixation cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=178&c_id=568" name="O" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS110142</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Osteotechnology, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Thompson type hip prothesis</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=179&c_id=569" name="O" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="O">PS200007</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Outset Medical Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tablo hemodialysis system </td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/12/2020</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=377&c_id=6125" name="O" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS090011</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Paradigm Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Dss stabilization system </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=17&c_id=319" name="P" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS160003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Parker Hannifin Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Indego</td> <td style="font-size: 8pt;" ROWSPAN="1">Neurology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/15/2016</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=358&c_id=3913" name="P" title="Reporting Schedule Details">Indego Postmarket Surveillance Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="P">PS150004</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Pentax Medical</td> <td style="font-size: 8pt;" ROWSPAN="2">Duodenoscopes</td> <td style="font-size: 8pt;" ROWSPAN="2">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">10/05/2015</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=355&c_id=3693" name="P" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=355&c_id=3727" name="P" title="Reporting Schedule Details">Sampling and Culturing Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS190003</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Pentax of America, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Duodenoscope</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/28/2019</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=364&c_id=5619" name="P" title="Reporting Schedule Details">Human Factors Study</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS190004</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Pentax of America, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Duodenoscope</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/28/2019</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=365&c_id=5620" name="P" title="Reporting Schedule Details">Sampling and Culturing</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS120047</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">PFM Medical</td> <td style="font-size: 8pt;" ROWSPAN="1">Timesh also known as timesh-tc models 6000001 & 6000004</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=233&c_id=638" name="P" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS060001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Philips Medical Systems, Heartstream</td> <td style="font-size: 8pt;" ROWSPAN="1">Philips heartstart home otc defibrillator</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">12/07/2005</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=3&c_id=273" name="P" title="Reporting Schedule Details">Non-Prescription Use</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS150001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Preceptis</td> <td style="font-size: 8pt;" ROWSPAN="1">Hummingbird tympanostomy tube system</td> <td style="font-size: 8pt;" ROWSPAN="1">Ear Nose & Throat</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/23/2015</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=352&c_id=3400" name="P" title="Reporting Schedule Details">Post-market Surveillance Study (PSS) </A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS130016</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Promedon</td> <td style="font-size: 8pt;" ROWSPAN="1">Ophira mini sling system</td> <td style="font-size: 8pt;" ROWSPAN="1">Gastroenterology/<br>Urology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=314&c_id=831" name="P" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS120066</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Promethean Surgical Devices, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Hydrocoat mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=252&c_id=657" name="P" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS120099</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Prosurg, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Minisling adjustable polymer sling & surgical mesh with self-anchoring system (easy lift prolapse repair & minisling)</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=285&c_id=690" name="P" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS130033</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Prosurg, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Zippere- bioabsorbable/non-absorbable polymer sling & surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=331&c_id=848" name="P" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS130034</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Prosurg, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Surgical mesh w/anchoring system</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=332&c_id=849" name="P" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="P">PS120067</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Proxy Biomedical Ltd.</td> <td style="font-size: 8pt;" ROWSPAN="1">Polyform synthetic mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=253&c_id=658" name="P" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="R">PS130008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Rmt Medical Technologies Ltd</td> <td style="font-size: 8pt;" ROWSPAN="1">Vena cava filter</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">02/28/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=306&c_id=813" name="R" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="R">PS120068</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">RTI Biologics, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tutopatch tutomesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=254&c_id=659" name="R" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="R">PS130036</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">RTI Biologics, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tutopatch</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=334&c_id=851" name="R" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120069</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Shelhigh, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Shelhigh porcine pericardial patch</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=255&c_id=660" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120070</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Shelhigh, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=256&c_id=661" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120062</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Smith & Nephew</td> <td style="font-size: 8pt;" ROWSPAN="1">Immix thin film models: Pss-004-s pss-004-sp pss-004-m pss-004-mp pss-004-l pss-004-lp</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=248&c_id=653" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120061</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Smith & Nephew, Inc</td> <td style="font-size: 8pt;" ROWSPAN="1">Immix plastifilm</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=247&c_id=652" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120073</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Sofradim Production</td> <td style="font-size: 8pt;" ROWSPAN="1">Ugytex mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=259&c_id=664" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120074</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Sofradim Production</td> <td style="font-size: 8pt;" ROWSPAN="1">Parietex</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=260&c_id=665" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120111</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">St. Jude Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Riata, quicksite, quickflex, durata</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/16/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=298&c_id=761" name="S" title="Reporting Schedule Details">Lead Externalization and Abrasion</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS130046</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">St. Jude Medical, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Amplatzer</td> <td style="font-size: 8pt;" ROWSPAN="1">Cardiovascular</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">09/13/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=345&c_id=1544" name="S" title="Reporting Schedule Details">ADVANCE ASO</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120025</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Stellen Medical</td> <td style="font-size: 8pt;" ROWSPAN="1">Brennen medical surgical mesh glucamesh/glucatex</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=211&c_id=616" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120026</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Stellen Medical</td> <td style="font-size: 8pt;" ROWSPAN="1">Dermmatrix surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=212&c_id=617" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120110</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Stryker Neurovascular</td> <td style="font-size: 8pt;" ROWSPAN="1">Wingspan stent system and gateway pta balloon catheter</td> <td style="font-size: 8pt;" ROWSPAN="1">Neurology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/08/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=297&c_id=762" name="S" title="Reporting Schedule Details">Rates of Stroke and Death</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS110144</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synergy Orthopaedics Intl., Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">S.A.F. Acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=181&c_id=571" name="S" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120063</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovation</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=249&c_id=654" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120064</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovation</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=250&c_id=655" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120017</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">Peri-strips</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=203&c_id=608" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120065</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=251&c_id=656" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120077</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">Veritas collagen matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=263&c_id=668" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120078</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations</td> <td style="font-size: 8pt;" ROWSPAN="1">Veritas collagen matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=264&c_id=669" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120016</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations / Baxter</td> <td style="font-size: 8pt;" ROWSPAN="1">Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips - sleeve peri-strips-strips peri-strips dry vasc</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=202&c_id=607" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120018</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations / Baxter</td> <td style="font-size: 8pt;" ROWSPAN="1">Supple peri-guard pericardium</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=204&c_id=609" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120019</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations / Baxter</td> <td style="font-size: 8pt;" ROWSPAN="1">Peri-guard pericardium</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=205&c_id=610" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS120020</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synovis Surgical Innovations / Baxter</td> <td style="font-size: 8pt;" ROWSPAN="1">Supple peri-guard pericardium</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=206&c_id=611" name="S" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS090010</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Synthes Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Ngarde system </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=16&c_id=318" name="S" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="S">PS090001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Szabocsik and Associates</td> <td style="font-size: 8pt;" ROWSPAN="1">Jsz orthokeratology contact lenses for overnight wear</td> <td style="font-size: 8pt;" ROWSPAN="1">Ophthalmic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">08/07/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=6&c_id=302" name="S" title="Reporting Schedule Details">Microbial Keratitis</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS190006</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tandem Diabetes Co.</td> <td style="font-size: 8pt;" ROWSPAN="1">Control-iq, algorithm</td> <td style="font-size: 8pt;" ROWSPAN="1">Clinical Chemistry</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">12/13/2019</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=368&c_id=5839" name="T" title="Reporting Schedule Details">Postmarket Surveillance Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS200008</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tandem Diabetes Co.</td> <td style="font-size: 8pt;" ROWSPAN="1">Control-iq technology</td> <td style="font-size: 8pt;" ROWSPAN="1">Clinical Chemistry</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">06/23/2020</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=378&c_id=6135" name="T" title="Reporting Schedule Details">Postmarket Surveillance</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS110145</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Techmedica, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=182&c_id=572" name="T" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS120080</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tei Biosciences Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tissuemend soft tissue repair matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=266&c_id=671" name="T" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS120082</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tei Biosciences Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Xenform soft tissue repair matrix</td> <td style="font-size: 8pt;" ROWSPAN="1">Obstetrics/<br>Gynecology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=268&c_id=673" name="T" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS120079</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tepha, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tephaflex surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=265&c_id=670" name="T" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS120107</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tepha, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tephaflex surgical film</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=293&c_id=740" name="T" title="Reporting Schedule Details">AE & Effectivenss Rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS120108</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Tepha, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Tephaflex composite mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">04/09/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=294&c_id=741" name="T" title="Reporting Schedule Details">AE & Effectineness Rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS130035</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">TFS Surgical</td> <td style="font-size: 8pt;" ROWSPAN="1">Tissue fixation system</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/15/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=333&c_id=850" name="T" title="Reporting Schedule Details">AE and Effectiveness Rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS060002</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">The Ohio State University</td> <td style="font-size: 8pt;" ROWSPAN="1">Paragon crt 100 lens and boston vision shaping treatment (vst) lens for ook</td> <td style="font-size: 8pt;" ROWSPAN="1">Ophthalmic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/25/2006</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=4&c_id=274" name="T" title="Reporting Schedule Details">Microbial Keratitis Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS110146</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Turnkey Intergration USA, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Modified freeman acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=183&c_id=573" name="T" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="T">PS110147</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Turnkey Intergration USA, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Modified freeman revision acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=184&c_id=574" name="T" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="U">PS090013</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ulrich Medical USA</td> <td style="font-size: 8pt;" ROWSPAN="1">Sscs hinged screws</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=19&c_id=321" name="U" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="U">PS090014</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Ulrich Medical USA</td> <td style="font-size: 8pt;" ROWSPAN="1">Cosmic system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=20&c_id=322" name="U" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="V">PS110001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Vermillion, Inc</td> <td style="font-size: 8pt;" ROWSPAN="1">Ova1</td> <td style="font-size: 8pt;" ROWSPAN="1">Immunology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/31/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=38&c_id=391" name="V" title="Reporting Schedule Details">OVA1 Performance in Pre and Post Menopausal Women</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS120083</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">W.L. Gore & Associates, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Seamguard staple line reinforcement material</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=269&c_id=674" name="W" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS120084</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">W.L. Gore & Associates, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Modification to seamguard staple line reinforcement material</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=270&c_id=675" name="W" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS120085</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">W.L. Gore & Associates, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Gore bioabsorbable mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=271&c_id=676" name="W" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS120086</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">W.L. Gore & Associates, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Seamguard staple line reinforcement material</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=272&c_id=677" name="W" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS110121</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Waldemar Link GMBH & Co. KG</td> <td style="font-size: 8pt;" ROWSPAN="1">Link cementless screw-in acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=158&c_id=523" name="W" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS110122</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Waldemar Link GMBH & Co. KG</td> <td style="font-size: 8pt;" ROWSPAN="1">Link cementless screw-in acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=159&c_id=524" name="W" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="W">PS130009</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Wright Medical Technology, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Linked metal-backed acetabular cups</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/20/2013</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=307&c_id=816" name="W" title="Reporting Schedule Details">PSS</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="X">PS120087</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Xylos Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Xylos porous surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=273&c_id=678" name="X" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="X">PS120088</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Xylos Corporation</td> <td style="font-size: 8pt;" ROWSPAN="1">Xylos porous surgical mesh</td> <td style="font-size: 8pt;" ROWSPAN="1">General & <br>Plastic Surgery</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">01/03/2012</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=274&c_id=679" name="X" title="Reporting Schedule Details">AE and effectiveness rates</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110092</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Zweymuller cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=129&c_id=494" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="Z">PS110093</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="2">Zweymueller-sl hip prosthesis stem</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=130&c_id=495" name="Z" title="Reporting Schedule Details">Cross-Sectional Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=130&c_id=2332" name="Z" title="Reporting Schedule Details">Explant Analysis</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110094</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Rs-cup acetabular prosthesis</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=131&c_id=496" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110096</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Converge reti-lock multi-hole reinforcement cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=133&c_id=498" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110097</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Epsilon metasul 32mm acetabular inserts, standard and hooded</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=134&c_id=499" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110098</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Alpha metasul 28mm and 32mm acetabular inserts, standard and hooded</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=135&c_id=500" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110100</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Modified anatomic porous replacement apr acetabula</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=137&c_id=502" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110101</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Schuster acetabular cup for cement/cementless fix</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=138&c_id=503" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110102</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Clx acetabular cup (wagner) for cementless fixation</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=139&c_id=504" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110105</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Apr metasul acetabular insert</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=142&c_id=507" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110106</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Inter-op metasul acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=143&c_id=508" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110107</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Inter-op metasul hooded and protrusio acetabular inserts</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=144&c_id=509" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110108</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Allofit acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=145&c_id=510" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110109</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Ascendent acetabular system</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=146&c_id=511" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Other</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110110</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Durom acetabular component and metasul ldh large diameter heads</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=147&c_id=512" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110111</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer porolock mis stem</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=148&c_id=513" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110112</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer mmc cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=149&c_id=514" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="Z">PS110113</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="2">Metasul taper liners, metasul femoral heads</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=150&c_id=515" name="Z" title="Reporting Schedule Details">Cross-sectional Plan</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=150&c_id=561" name="Z" title="Reporting Schedule Details">Prospective Study plan</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110114</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer threaded acetabular cup</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=151&c_id=516" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="Z">PS110115</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer m/l taper hip prosthesis with modular neck technology</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=152&c_id=517" name="Z" title="Reporting Schedule Details">Cross-sectional Plan</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=152&c_id=562" name="Z" title="Reporting Schedule Details">Prospective Study Plan</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="Z">PS110116</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer m/l taper hip prosthesis with kinectiv technology system, model(s) 7848 series( modular necks), 7713 series</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=153&c_id=518" name="Z" title="Reporting Schedule Details">Cross-sectional Plan</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=153&c_id=563" name="Z" title="Reporting Schedule Details">Prospective Study Plan</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS110117</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="1">Versys epoch fullcoat hip prosthesis, model 4088 series</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=154&c_id=519" name="Z" title="Reporting Schedule Details">Metal ion levels</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="2" align="center"> <A name="Z">PS110118</A> </td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer</td> <td style="font-size: 8pt;" ROWSPAN="2">Zimmer m/l taper hip prosthesis with kinectiv technology system</td> <td style="font-size: 8pt;" ROWSPAN="2">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="2">05/06/2011</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=155&c_id=520" name="Z" title="Reporting Schedule Details">Cross-sectional Plan</A> </TD> <TD style="font-size: 8pt;">Consolidated</TD> </TR> <TR valign="top" BGCOLOR="#f9f9f3" style="font-family: arial; color: #000000;"> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=155&c_id=564" name="Z" title="Reporting Schedule Details">Prospective Study Plan</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS090016</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer® dynesys® spinal system with dto implant</td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=22&c_id=324" name="Z" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS090017</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer Spine</td> <td style="font-size: 8pt;" ROWSPAN="1">Zimmer® dynesys® top-loading spinal system </td> <td style="font-size: 8pt;" ROWSPAN="1">Orthopedic</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">10/05/2009</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=23&c_id=325" name="Z" title="Reporting Schedule Details">Fusion, AEs, Surg Procedures</A> </TD> <TD style="font-size: 8pt;">Terminated</TD> </TR> <tr valign="top" bgcolor="#f9f9f3" style="font-family: arial; color: #000000;"> <td style="font-size: 8pt;" ROWSPAN="1" align="center"> <A name="Z">PS040001</A> </td> <td style="font-size: 8pt;" ROWSPAN="1">ZOLL Circulation, Inc.</td> <td style="font-size: 8pt;" ROWSPAN="1">Alsius coolgard 3000/coolline catheter thermal regulation system</td> <td style="font-size: 8pt;" ROWSPAN="1">Neurology</td> <td align="center" style="font-size: 8pt;" ROWSPAN="1">03/05/2004</td> <TD style="font-size: 8pt;" width="80px"> <a href="../cfPMA/pss.cfm?t_id=2&c_id=272" name="Z" title="Reporting Schedule Details">Mortality Study</A> </TD> <TD style="font-size: 8pt;">Completed</TD> </TR> </table> </td> </tr> </table> <br><br> <A name="Contact_Us"></A> <div class="pss-intro"> <h3 style="font-family: arial; color: #23238E;"><a name="guidance">Contact Us</a></h3> <hr style="text-decoration:underline;"> <blockquote style="font-family: arial; font-size: 9pt;"> Mandated Studies Program<br> Food and Drug Administration<br> 10903 New Hampshire Ave.<br> Silver Spring, MD 20993-0002<br> Email: MandatedStudiesPrograms@fda.hhs.gov<br> </blockquote> <A name="522_Background"></A> <A name="522_Resources_Guidance"></A> <h3 style="font-family: arial; color: #23238E;"><a name="guidance">Additional Resources</a></h3> <hr style="text-decoration:underline;"> <ul style="font-family: arial; font-size: 9pt;"> <li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act">Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry and Food and Drug Administration Staff</a></li> <li><a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/522-postmarket-surveillance-studies">522 Program Background</a></li> </ul> </div>  </span> <div class="clearfloat"> - </div> </div> <div class="clearfloat"> - </div>   <script type="text/javascript"> setStyle(); </script>   <div id="footer">  <div id="footnote"><h4>Links on this page:</h4><div></div></div>   <div id="pagetools_bottom"> <div id="pagetools_right"> <p>Page Last Updated: 11/25/2024</p> <p> Note: If you need help accessing information in different file formats, see <a href="https://www.fda.gov/about-fda/website-policies/viewing-files">Instructions for Downloading Viewers and Players</a>. <br>Language Assistance Available: <a title="Spanish" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#spanish">Español</a> | <a title="Chinese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#chinese">繁體中文</a> | <a title="Vietnamese" 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