This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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 | 1981-01-22 |
| Decision Date | 1982-12-17 |
| Notice Date | 1983-03-01 |
| PMA | P810002 |
| Supplement | S |
| Product Code | LWQ |
| Docket Number | 83M-0004 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. one Lillehei Plaza st. Paul, MN 55117 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| 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 |