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 an extra lead port to the the endotak sq array xp subcutaneous lead model 0049 and a modified df-1 terminal of: the endotak sq array xp subcutaneous lead model 0049; endotak sq patch lead model 0047; endotak sq array subcutaneous lead model 0049; df-1 lead adapters models 6833, 6835, 6931 and the epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
| Device | ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2000-01-14 |
| Decision Date | 2000-04-11 |
| PMA | P910073 |
| Supplement | S031 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |