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 | ENDOTAK(R) LEAD SYSTEM |
Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1994-12-23 |
Decision Date | 1995-04-13 |
PMA | P910073 |
Supplement | S010 |
Product Code | LWS |
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 | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
Supplement Number | Date | Supplement Type |
---|---|---|
P910073 | Original Filing | |
S171 | 2023-01-05 | 30-day Notice |
S170 | 2022-11-01 | 30-day Notice |
S169 | 2022-10-07 | 30-day Notice |
S168 | 2022-02-23 | 30-day Notice |
S167 | 2021-09-30 | 30-day Notice |
S166 | 2021-09-30 | 30-day Notice |
S165 | ||
S164 | 2021-09-23 | 30-day Notice |
S163 | 2021-09-01 | 30-day Notice |
S162 | 2021-05-25 | 30-day Notice |
S161 | 2021-04-30 | 30-day Notice |
S160 | 2021-03-08 | 30-day Notice |
S159 | 2021-01-11 | 30-day Notice |
S158 | 2020-10-08 | Normal 180 Day Track No User Fee |
S157 | 2020-04-16 | Normal 180 Day Track No User Fee |
S156 | 2019-05-21 | 30-day Notice |
S155 | ||
S154 | 2019-03-13 | 30-day Notice |
S153 | 2018-12-26 | Real-time Process |
S152 | 2018-12-20 | 30-day Notice |
S151 | 2018-10-26 | 30-day Notice |
S150 | 2018-07-13 | 30-day Notice |
S149 | 2018-04-25 | 30-day Notice |
S148 | 2018-03-26 | 30-day Notice |
S147 | 2017-12-19 | 30-day Notice |
S146 | 2017-12-19 | Normal 180 Day Track |
S145 | 2017-12-12 | Normal 180 Day Track |
S144 | 2017-11-20 | 30-day Notice |
S143 | 2017-06-07 | 30-day Notice |
S142 | 2017-05-26 | Normal 180 Day Track |
S141 | 2017-03-30 | 30-day Notice |
S140 | 2016-12-14 | 30-day Notice |
S139 | 2016-07-25 | 30-day Notice |
S138 | 2016-07-18 | Normal 180 Day Track |
S137 | 2016-07-07 | 30-day Notice |
S136 | 2016-06-27 | 30-day Notice |
S135 | 2016-05-27 | 30-day Notice |
S134 | 2016-04-06 | 30-day Notice |
S133 | 2015-11-20 | 135 Review Track For 30-day Notice |
S132 | 2015-08-07 | Normal 180 Day Track |
S131 | ||
S130 | 2015-06-22 | 30-day Notice |
S129 | 2014-12-22 | Normal 180 Day Track |
S128 | 2014-09-03 | Normal 180 Day Track |
S127 | 2014-06-30 | 30-day Notice |
S126 | 2014-06-09 | 30-day Notice |
S125 | 2014-04-22 | 30-day Notice |
S124 | 2014-02-21 | Real-time Process |
S123 | 2014-01-28 | Real-time Process |
S122 | 2013-12-23 | Normal 180 Day Track |
S121 | 2013-08-29 | 30-day Notice |
S120 | 2013-08-19 | 30-day Notice |
S119 | ||
S118 | 2013-05-28 | Real-time Process |
S117 | 2013-05-16 | Real-time Process |
S116 | 2013-03-19 | Real-time Process |
S115 | 2013-01-04 | Real-time Process |
S114 | 2012-11-21 | 30-day Notice |
S113 | 2012-11-13 | 30-day Notice |
S112 | 2012-11-08 | 30-day Notice |
S111 | 2012-10-16 | 30-day Notice |
S110 | 2012-10-09 | 30-day Notice |
S109 | 2012-10-02 | 30-day Notice |
S108 | 2012-10-05 | 30-day Notice |
S107 | 2012-09-28 | Normal 180 Day Track |
S106 | 2012-09-04 | 30-day Notice |
S105 | 2012-07-26 | Real-time Process |
S104 | 2012-06-19 | 30-day Notice |
S103 | 2012-06-15 | 30-day Notice |
S102 | 2012-05-14 | Normal 180 Day Track No User Fee |
S101 | 2012-03-26 | 30-day Notice |
S100 | 2012-01-24 | 30-day Notice |
S099 | 2011-10-21 | 30-day Notice |
S098 | 2011-05-25 | 30-day Notice |
S097 | 2011-05-04 | 30-day Notice |
S096 | 2011-04-01 | 30-day Notice |
S095 | 2011-04-01 | 30-day Notice |
S094 | 2011-03-28 | Real-time Process |
S093 | 2011-03-01 | 30-day Notice |
S092 | 2010-12-17 | Real-time Process |
S091 | 2010-12-14 | Normal 180 Day Track |
S090 | 2010-11-16 | 30-day Notice |
S089 | 2010-10-29 | 135 Review Track For 30-day Notice |
S088 | ||
S087 | ||
S086 | 2010-08-10 | 30-day Notice |
S085 | 2010-07-14 | 30-day Notice |
S084 | 2010-04-26 | 135 Review Track For 30-day Notice |
S083 | 2010-04-23 | 30-day Notice |
S082 | 2009-12-18 | 30-day Notice |
S081 | 2009-12-16 | 30-day Notice |
S080 | ||
S079 | 2009-08-24 | 30-day Notice |
S078 | 2009-05-08 | 30-day Notice |
S077 | 2009-02-24 | Normal 180 Day Track |
S076 | 2008-09-17 | 30-day Notice |
S075 | 2008-09-12 | Real-time Process |
S074 | 2008-09-10 | 30-day Notice |
S073 | 2008-05-02 | 135 Review Track For 30-day Notice |
S072 | 2008-03-21 | Real-time Process |
S071 | ||
S070 | ||
S069 | ||
S068 | 2007-11-13 | 30-day Notice |
S067 | 2007-07-16 | 30-day Notice |
S066 | ||
S065 | 2006-04-13 | 30-day Notice |
S064 | 2006-04-13 | 30-day Notice |
S063 | ||
S062 | 2006-01-06 | Real-time Process |
S061 | 2005-12-02 | 30-day Notice |
S060 | 2005-11-23 | 30-day Notice |
S059 | 2005-11-09 | 30-day Notice |
S058 | 2005-10-26 | 30-day Notice |
S057 | 2005-10-24 | 30-day Notice |
S056 | 2005-09-19 | 30-day Notice |
S055 | 2005-10-06 | Real-time Process |
S054 | 2005-08-25 | 30-day Notice |
S053 | 2005-08-01 | 30-day Notice |
S052 | 2005-07-08 | 30-day Notice |
S051 | 2005-06-15 | 30-day Notice |
S050 | 2005-02-24 | 30-day Notice |
S049 | 2004-12-03 | 30-day Notice |
S048 | 2004-10-21 | 30-day Notice |
S047 | 2004-08-17 | 30-day Notice |
S046 | 2004-06-14 | 30-day Notice |
S045 | 2004-04-14 | 30-day Notice |
S044 | 2004-01-13 | 30-day Notice |
S043 | 2003-12-04 | Real-time Process |
S042 | 2003-05-05 | Real-time Process |
S041 | 2003-03-04 | Normal 180 Day Track |
S040 | 2002-11-13 | 30-day Notice |
S039 | 2002-03-11 | Normal 180 Day Track |
S038 | 2001-11-21 | Real-time Process |
S037 | 2000-12-01 | Real-time Process |
S036 | 2000-07-06 | Normal 180 Day Track |
S035 | 2000-09-13 | Real-time Process |
S034 | 2000-08-21 | Normal 180 Day Track |
S033 | 2000-07-12 | Real-time Process |
S032 | 2000-06-26 | Real-time Process |
S031 | 2000-01-14 | Real-time Process |
S030 | 2000-01-11 | Real-time Process |
S029 | 1999-12-16 | Normal 180 Day Track |
S028 | 2000-01-11 | Real-time Process |
S027 | 1999-07-26 | Real-time Process |
S026 | 1999-03-19 | Normal 180 Day Track |
S025 | 1998-07-30 | Normal 180 Day Track |
S024 | 1998-02-19 | Normal 180 Day Track |
S023 | 1997-10-16 | Real-time Process |
S022 | 1997-04-03 | Normal 180 Day Track |
S021 | 1996-10-16 | Normal 180 Day Track |
S020 | 1996-05-10 | Normal 180 Day Track |
S019 | 1995-10-02 | Normal 180 Day Track |
S018 | 1995-09-01 | Normal 180 Day Track |
S017 | 1995-05-19 | Normal 180 Day Track |
S016 | 1995-05-12 | Normal 180 Day Track |
S015 | 1995-05-01 | Normal 180 Day Track |
S014 | 1995-04-24 | Normal 180 Day Track |
S013 | 1995-03-30 | Normal 180 Day Track |
S012 | ||
S011 | 1995-01-30 | Normal 180 Day Track |
S010 | 1994-12-23 | Normal 180 Day Track |
S009 | ||
S008 | 1994-12-14 | Normal 180 Day Track |
S007 | 1994-11-23 | Normal 180 Day Track |
S006 | ||
S005 | 1994-08-22 | Normal 180 Day Track |
S004 | 1994-08-05 | Normal 180 Day Track |
S003 | 1994-07-01 | Normal 180 Day Track |
S002 | 1993-12-21 | Normal 180 Day Track |
S001 | 1993-12-01 | Normal 180 Day Track |