This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Premarket approval (pma) // quick links: skip to main page content skip to search skip to topics menu skip to common links u. S. Food & drug administration follow fda en español search fda home food drugs medical devices radiation-emitting products vaccines, blood & biologics animal & veterinary cosmetics tobacco products premarket approval (pma) var mp = { version: '1. 0. 22', domains: {'es':'esp. Fda. Gov'}, srclang: 'en', urllang: 'mp_js_current_lang', srcurl: unescape('mp_js_orgin_url'), init: function(){ if (mp. Urllang. Indexof('p_js_')==1) { mp. Srcurl=window. Top. Document. Location. Href; mp. Urllang=mp. Srclang; } }, getcookie: function(name){ var start=document. Cookie. Indexof(name+'='); if(start < 0) return null; start=start+name. Length+1; var end=document. Cookie. Indexof(';', start); if(end < 0) end=document. Cookie. Length; while (document. Cookie. Charat(start)==' '){ start++; } return unescape(document. Cookie. Substring(start,end)); }, setcookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new date(); now. Settime(now. Gettime()+1000*60*60*24*365); cookie+='; expires='+now. Toutcstring(); document. Cookie=cookie; }, switchlanguage: function(lang){ if(lang! =mp. Srclang){ var script=document. Createelement('script'); script. Src=location. Protocol+'//'+mp. Domains[lang]+'/'+mp. Srclang+lang+'/? 1023749632;'+encodeuricomponent(mp. Srcurl); document. Body. Appendchild(script); } else if(lang==mp. Srclang && mp. Urllang! =mp. Srclang){ var script=document. Createelement('script'); script. Src=location. Protocol+'//'+mp. Domains[mp. Urllang]+'/'+mp. Srclang+mp. Urllang+'/? 1023749634;'+encodeuricomponent(location. Href); document. Body. Appendchild(script); } return false; }, switchtolang: function(url) { window. Top. Location. Href=url; } }; var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ; fda home medical devices databases -. Pma { color: #000000; width: 900px; float: right; margin: 0px 25px 0px 0px; }. Pma-left { color: #000000; float: left; width: 610px; margin: 9px 30px 0px 0; }. Pma-right { color: #000000; float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; }. Pma-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #pma-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #pma-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #pma-form-title-left { font-size: 13px; font-weight: bold; } #pma-form-title-right { font-size: 11px; padding: 0px 0px 0px 300px; } #pma-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #pma-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #pma-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #pma-results-table tr:nth-child(odd) { background-color: #f3f3f3; }. Sort { float: right; margin-top: 5px;}. Sort a { color: #484138; }. Sort a:hover { color: #0f2a8c; }
| Device | BILEAFLET-CENTER OPENING CARDIAC VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 1988-06-15 |
| Decision Date | 1991-09-30 |
| PMA | P810002 |
| Supplement | S018 |
| Product Code | LWQ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. one Lillehei Plaza st. Paul, MN 55117 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810002 | Original Filing | |
| S116 | 2022-12-28 | 30-day Notice |
| S115 | 2021-11-10 | 30-day Notice |
| S114 | 2021-09-20 | 30-day Notice |
| S113 | 2021-07-23 | Special (immediate Track) |
| S112 | 2020-05-05 | 30-day Notice |
| S111 | 2020-04-28 | 30-day Notice |
| S110 | ||
| S109 | 2019-02-27 | 30-day Notice |
| S108 | ||
| S107 | 2018-04-09 | Normal 180 Day Track No User Fee |
| S106 | 2018-02-01 | 30-day Notice |
| S105 | 2017-09-08 | Real-time Process |
| S104 | ||
| S103 | 2017-07-19 | 30-day Notice |
| S102 | ||
| S101 | 2017-06-21 | Normal 180 Day Track |
| S100 | 2016-12-30 | 30-day Notice |
| S099 | 2016-11-28 | 30-day Notice |
| S098 | 2016-09-29 | Real-time Process |
| S097 | 2016-03-29 | 30-day Notice |
| S096 | 2015-03-10 | 30-day Notice |
| S095 | 2015-02-25 | 30-day Notice |
| S094 | 2015-01-20 | 30-day Notice |
| S093 | 2015-01-12 | 30-day Notice |
| S092 | 2014-11-21 | 30-day Notice |
| S091 | 2014-11-12 | 30-day Notice |
| S090 | 2014-05-19 | 135 Review Track For 30-day Notice |
| S089 | 2014-03-10 | 30-day Notice |
| S088 | 2013-12-03 | 30-day Notice |
| S087 | 2013-07-05 | 30-day Notice |
| S086 | 2013-05-28 | 30-day Notice |
| S085 | 2013-04-30 | 30-day Notice |
| S084 | 2013-04-04 | 135 Review Track For 30-day Notice |
| S083 | 2012-06-28 | 30-day Notice |
| S082 | 2012-03-13 | 135 Review Track For 30-day Notice |
| S081 | 2012-02-29 | 30-day Notice |
| S080 | 2012-02-07 | Normal 180 Day Track No User Fee |
| S079 | 2012-02-01 | 30-day Notice |
| S078 | 2011-08-17 | Real-time Process |
| S077 | 2011-07-05 | 135 Review Track For 30-day Notice |
| S076 | 2011-06-13 | Real-time Process |
| S075 | ||
| S074 | 2011-02-16 | 135 Review Track For 30-day Notice |
| S073 | 2011-02-16 | 30-day Notice |
| S072 | 2010-12-02 | 30-day Notice |
| S071 | 2010-06-02 | 30-day Notice |
| S070 | 2009-04-15 | 30-day Notice |
| S069 | 2009-03-09 | Normal 180 Day Track No User Fee |
| S068 | 2008-10-14 | Real-time Process |
| S067 | 2008-07-03 | Real-time Process |
| S066 | 2008-06-17 | 30-day Notice |
| S065 | 2008-06-03 | Normal 180 Day Track No User Fee |
| S064 | 2008-04-14 | 30-day Notice |
| S063 | 2008-02-25 | Normal 180 Day Track No User Fee |
| S062 | 2007-09-13 | 135 Review Track For 30-day Notice |
| S061 | 2006-11-21 | Real-time Process |
| S060 | 2006-10-23 | 135 Review Track For 30-day Notice |
| S059 | 2006-03-31 | Real-time Process |
| S058 | 2005-01-03 | Real-time Process |
| S057 | 2001-09-07 | Normal 180 Day Track |
| S056 | 2001-03-26 | Real-time Process |
| S055 | 2001-01-29 | Normal 180 Day Track |
| S054 | 2000-09-27 | Real-time Process |
| S053 | 2000-07-28 | Normal 180 Day Track |
| S052 | 2000-05-22 | Normal 180 Day Track |
| S051 | 2000-04-12 | Real-time Process |
| S050 | 1999-09-22 | Normal 180 Day Track |
| S049 | 1999-02-09 | Normal 180 Day Track |
| S048 | 1998-11-04 | Normal 180 Day Track |
| S047 | 1998-06-26 | 30-day Notice |
| S046 | 1997-05-15 | Normal 180 Day Track |
| S045 | 1997-05-05 | Normal 180 Day Track |
| S044 | 1997-04-23 | Normal 180 Day Track |
| S043 | 1997-02-27 | Normal 180 Day Track |
| S042 | 1996-04-17 | Special (immediate Track) |
| S041 | 1996-03-07 | Normal 180 Day Track |
| S040 | 1995-09-11 | Normal 180 Day Track |
| S039 | 1995-09-11 | Normal 180 Day Track |
| S038 | 1995-08-15 | Normal 180 Day Track |
| S037 | 1995-07-03 | Special (immediate Track) |
| S036 | 1995-05-05 | Normal 180 Day Track |
| S035 | 1995-02-03 | Normal 180 Day Track |
| S034 | 1994-12-12 | Normal 180 Day Track |
| S033 | 1994-12-09 | Normal 180 Day Track |
| S032 | 1994-06-24 | Normal 180 Day Track |
| S031 | ||
| S030 | 1994-03-16 | Normal 180 Day Track |
| S029 | 1994-03-02 | Normal 180 Day Track |
| S028 | 1994-03-02 | Normal 180 Day Track |
| S027 | 1993-07-15 | Normal 180 Day Track |
| S026 | 1993-07-01 | Normal 180 Day Track |
| S025 | 1993-01-04 | Normal 180 Day Track |
| S024 | 1992-04-17 | Normal 180 Day Track |
| S023 | ||
| S022 | 1991-09-20 | Normal 180 Day Track |
| S021 | 1991-05-06 | Normal 180 Day Track |
| S020 | 1990-12-17 | Special (immediate Track) |
| S019 | 1990-06-26 | Normal 180 Day Track |
| S018 | 1988-06-15 | Normal 180 Day Track |
| S017 | 1988-05-25 | Normal 180 Day Track |
| S016 | 1987-12-31 | Special (immediate Track) |
| S015 | 1987-11-23 | Normal 180 Day Track |
| S014 | 1987-11-13 | Normal 180 Day Track |
| S013 | 1987-05-04 | Normal 180 Day Track |
| S012 | 1986-12-23 | Normal 180 Day Track |
| S011 | 1986-12-22 | Special (immediate Track) |
| S010 | 1986-08-27 | Normal 180 Day Track |
| S009 | 1986-07-23 | Normal 180 Day Track |
| S008 | 1986-06-14 | Normal 180 Day Track |
| S007 | ||
| S006 | 1984-07-27 | |
| S005 | ||
| S004 | 1984-01-27 | |
| S003 | 1983-04-11 | |
| S002 | 1983-03-17 | |
| S001 | 1983-02-28 |