Approval for adding language in the implant manuals of the referenced devices which states and clarifies that good tissue contact with the electrode and pulse generator is important for optimizing sensing and therapy delivery.
| Device | SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2014-06-16 |
| Decision Date | 2014-06-27 |
| PMA | P110042 |
| Supplement | S039 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110042 | | Original Filing |
| S177 |
2022-12-07 |
30-day Notice |
| S176 |
2022-11-10 |
30-day Notice |
| S175 |
2022-10-05 |
30-day Notice |
| S174 | | |
| S173 | | |
| S172 |
2022-09-20 |
30-day Notice |
| S171 |
2022-06-29 |
30-day Notice |
| S170 |
2022-06-16 |
30-day Notice |
| S169 |
2022-04-25 |
Normal 180 Day Track No User Fee |
| S168 |
2021-12-16 |
30-day Notice |
| S167 | | |
| S166 | | |
| S165 |
2021-10-08 |
30-day Notice |
| S164 | | |
| S163 |
2021-09-30 |
30-day Notice |
| S162 |
2021-09-23 |
30-day Notice |
| S161 | | |
| S160 | | |
| S159 | | |
| S158 |
2021-09-01 |
30-day Notice |
| S157 |
2021-06-21 |
Real-time Process |
| S156 |
2021-04-26 |
30-day Notice |
| S155 |
2021-03-29 |
30-day Notice |
| S154 | | |
| S153 |
2021-03-08 |
30-day Notice |
| S152 |
2021-01-11 |
30-day Notice |
| S151 |
2020-12-10 |
30-day Notice |
| S150 | | |
| S149 |
2020-11-03 |
30-day Notice |
| S148 | | |
| S147 | | |
| S146 |
2020-09-24 |
30-day Notice |
| S145 |
2020-08-25 |
30-day Notice |
| S144 | | |
| S143 | | |
| S142 | | |
| S141 |
2020-07-27 |
30-day Notice |
| S140 |
2020-07-08 |
30-day Notice |
| S139 |
2020-06-24 |
30-day Notice |
| S138 |
2020-05-27 |
30-day Notice |
| S137 | | |
| S136 |
2020-04-06 |
30-day Notice |
| S135 |
2020-03-13 |
30-day Notice |
| S134 |
2020-03-02 |
30-day Notice |
| S133 | | |
| S132 |
2019-12-23 |
Normal 180 Day Track |
| S131 |
2019-11-22 |
30-day Notice |
| S130 |
2019-10-21 |
30-day Notice |
| S129 | | |
| S128 |
2019-09-18 |
30-day Notice |
| S127 |
2019-08-30 |
30-day Notice |
| S126 |
2019-06-14 |
30-day Notice |
| S125 |
2019-03-20 |
Real-time Process |
| S124 |
2019-03-13 |
30-day Notice |
| S123 |
2019-03-04 |
Real-time Process |
| S122 |
2019-03-01 |
30-day Notice |
| S121 |
2018-12-26 |
30-day Notice |
| S120 |
2018-12-26 |
Real-time Process |
| S119 |
2018-12-03 |
Real-time Process |
| S118 |
2018-11-27 |
30-day Notice |
| S117 |
2018-11-08 |
30-day Notice |
| S116 |
2018-10-19 |
30-day Notice |
| S115 |
2018-10-05 |
30-day Notice |
| S114 |
2018-09-26 |
30-day Notice |
| S113 |
2018-09-04 |
30-day Notice |
| S112 |
2018-08-30 |
30-day Notice |
| S111 |
2018-07-13 |
30-day Notice |
| S110 |
2018-05-22 |
30-day Notice |
| S109 |
2018-05-07 |
30-day Notice |
| S108 |
2018-05-02 |
30-day Notice |
| S107 |
2018-04-17 |
30-day Notice |
| S106 |
2018-03-26 |
30-day Notice |
| S105 |
2018-03-05 |
30-day Notice |
| S104 |
2018-02-16 |
30-day Notice |
| S103 |
2018-01-19 |
30-day Notice |
| S102 |
2017-12-19 |
Normal 180 Day Track |
| S101 |
2017-12-19 |
30-day Notice |
| S100 |
2017-12-18 |
30-day Notice |
| S099 |
2017-12-18 |
30-day Notice |
| S098 |
2017-11-21 |
30-day Notice |
| S097 |
2017-11-20 |
30-day Notice |
| S096 |
2017-11-02 |
30-day Notice |
| S095 |
2017-10-30 |
30-day Notice |
| S094 |
2017-09-28 |
30-day Notice |
| S093 |
2017-09-20 |
30-day Notice |
| S092 |
2017-09-15 |
Real-time Process |
| S091 |
2017-08-04 |
30-day Notice |
| S090 |
2017-07-24 |
30-day Notice |
| S089 |
2017-07-18 |
Real-time Process |
| S088 |
2017-07-17 |
Real-time Process |
| S087 |
2017-06-07 |
Real-time Process |
| S086 |
2017-05-22 |
Real-time Process |
| S085 |
2017-05-10 |
30-day Notice |
| S084 |
2017-04-28 |
30-day Notice |
| S083 |
2017-04-03 |
Normal 180 Day Track |
| S082 |
2017-03-29 |
30-day Notice |
| S081 |
2017-03-27 |
30-day Notice |
| S080 |
2017-03-27 |
Real-time Process |
| S079 |
2017-02-22 |
30-day Notice |
| S078 |
2017-02-07 |
30-day Notice |
| S077 |
2017-02-06 |
Normal 180 Day Track |
| S076 |
2017-02-03 |
30-day Notice |
| S075 |
2017-01-23 |
30-day Notice |
| S074 |
2016-12-20 |
30-day Notice |
| S073 |
2016-12-19 |
30-day Notice |
| S072 |
2016-12-14 |
30-day Notice |
| S071 |
2016-11-22 |
30-day Notice |
| S070 |
2016-11-22 |
Real-time Process |
| S069 |
2016-10-31 |
30-day Notice |
| S068 |
2016-10-26 |
Normal 180 Day Track |
| S067 |
2016-10-19 |
Normal 180 Day Track |
| S066 |
2016-10-03 |
30-day Notice |
| S065 |
2016-09-16 |
30-day Notice |
| S064 |
2016-09-12 |
30-day Notice |
| S063 |
2016-09-02 |
30-day Notice |
| S062 |
2016-08-17 |
30-day Notice |
| S061 |
2016-07-07 |
30-day Notice |
| S060 |
2016-07-01 |
Real-time Process |
| S059 |
2016-04-21 |
Real-time Process |
| S058 |
2016-02-12 |
Normal 180 Day Track |
| S057 |
2015-12-21 |
Real-time Process |
| S056 |
2015-11-13 |
30-day Notice |
| S055 |
2015-11-04 |
30-day Notice |
| S054 | | |
| S053 |
2015-10-14 |
30-day Notice |
| S052 |
2015-09-30 |
30-day Notice |
| S051 |
2015-09-23 |
30-day Notice |
| S050 |
2015-09-17 |
30-day Notice |
| S049 |
2015-07-29 |
30-day Notice |
| S048 | | |
| S047 | | |
| S046 | | |
| S045 |
2015-04-27 |
Real-time Process |
| S044 | | |
| S043 |
2014-11-14 |
Normal 180 Day Track |
| S042 |
2014-11-03 |
30-day Notice |
| S041 |
2014-09-29 |
30-day Notice |
| S040 |
2014-08-11 |
30-day Notice |
| S039 |
2014-06-16 |
Special (immediate Track) |
| S038 |
2014-06-12 |
Normal 180 Day Track No User Fee |
| S037 |
2014-06-02 |
30-day Notice |
| S036 | | |
| S035 |
2014-05-08 |
30-day Notice |
| S034 |
2014-05-08 |
30-day Notice |
| S033 |
2014-05-05 |
30-day Notice |
| S032 |
2014-04-14 |
30-day Notice |
| S031 |
2014-04-09 |
30-day Notice |
| S030 | | |
| S029 |
2014-03-18 |
Normal 180 Day Track |
| S028 |
2014-03-18 |
30-day Notice |
| S027 |
2014-02-21 |
30-day Notice |
| S026 |
2014-01-14 |
30-day Notice |
| S025 |
2014-01-10 |
30-day Notice |
| S024 |
2013-12-23 |
30-day Notice |
| S023 |
2013-11-20 |
30-day Notice |
| S022 |
2013-11-13 |
30-day Notice |
| S021 |
2013-11-06 |
30-day Notice |
| S020 |
2013-11-06 |
Normal 180 Day Track |
| S019 |
2013-10-30 |
30-day Notice |
| S018 |
2013-10-23 |
30-day Notice |
| S017 |
2013-09-03 |
Normal 180 Day Track No User Fee |
| S016 |
2013-09-03 |
Real-time Process |
| S015 |
2013-08-30 |
30-day Notice |
| S014 |
2013-08-05 |
Real-time Process |
| S013 |
2013-08-01 |
30-day Notice |
| S012 |
2013-07-02 |
Real-time Process |
| S011 |
2013-06-21 |
Real-time Process |
| S010 |
2013-06-14 |
30-day Notice |
| S009 |
2013-06-10 |
Normal 180 Day Track |
| S008 |
2013-04-22 |
30-day Notice |
| S007 |
2013-04-04 |
Real-time Process |
| S006 |
2013-03-18 |
30-day Notice |
| S005 |
2013-02-28 |
Real-time Process |
| S004 |
2013-01-11 |
Real-time Process |
| S003 |
2012-12-13 |
Real-time Process |
| S002 |
2012-12-10 |
Normal 180 Day Track |
| S001 |
2012-11-13 |
30-day Notice |
NIH GUDID Devices