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.
Approval for the endotak c lead (models 0060, 0062, 0064, 0065, 0066, 0067, and 0068), endotak sq patch lead (model 0047 and 0063), endotak c lead (models 0070, 0072, 0073, 0074, 0075, 0113, and 0115), endotak sq lead array (models 0048 and 0049), and endotak dsp lead (models 0092, 0093, 0094, 0095, 0096, 0097, 0123, and 0125), which requested approval to add a patient group to the indications for use
| Device | ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1996-05-10 |
| Decision Date | 1996-05-15 |
| PMA | P910073 |
| Supplement | S020 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |