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.
| Device | Subcutaneous ICD s: EMBLEM |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2019-03-20 |
| Decision Date | 2019-06-10 |
| PMA | P110042 |
| Supplement | S125 |
| 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 CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00802526531033 | P110042 | 000 |
| 00802526553707 | P110042 | 000 |
| 00802526521300 | P110042 | 000 |
| 00802526524806 | P110042 | 000 |
| 00802526531019 | P110042 | 000 |
| 00802526542220 | P110042 | 009 |
| 00802526542206 | P110042 | 009 |
| 00802526542244 | P110042 | 009 |
| 00802526562808 | P110042 | 017 |
| 00802526563201 | P110042 | 017 |
| 00802526569401 | P110042 | 033 |
| 00802526580604 | P110042 | 043 |
| 00802526544101 | P110042 | 043 |
| 00802526600609 | P110042 | 043 |
| 00802526581830 | P110042 | 043 |
| 00802526581809 | P110042 | 043 |
| 00802526573507 | P110042 | 043 |
| 00802526575600 | P110042 | 043 |
| 00802526575907 | P110042 | 043 |
| 00802526579103 | P110042 | 043 |
| 00802526605345 | P110042 | 058 |
| 00802526584404 | P110042 | 058 |
| 00802526585968 | P110042 | 058 |
| 00802526585982 | P110042 | 058 |
| 00802526586507 | P110042 | 058 |
| 00802526599200 | P110042 | 077 |
| 00802526591907 | P110042 | 102 |
| 00802526609206 | P110042 | 123 |
| 00802526610516 | P110042 | 123 |
| 00802526615108 | P110042 | 132 |