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 | EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS176 Date Received11/10/2022 Decision Date12/07/2022 Product Codes LWS NVY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-10 |
| Decision Date | 2022-12-07 |
| PMA | P110042 |
| Supplement | S176 |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS176 Date Received11/10/2022 Decision Date12/07/2022 Product Codes LWS NVY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement modification Of Electrical Test Software To Ensure That The Correct Date And Time Stamp Are Loaded At Final Pack Of The EMBLEM S-ICD Pulse Generators |
| 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 |