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.
Changes to the carrier tube extrusion line.
| Device | Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2017-04-11 |
| Decision Date | 2017-05-10 |
| PMA | P150003 |
| Supplement | S029 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150003 | Original Filing | |
| S089 | 2022-11-14 | 30-day Notice |
| S088 | ||
| S087 | 2022-05-06 | 30-day Notice |
| S086 | 2022-05-02 | 30-day Notice |
| S085 | 2022-04-07 | 30-day Notice |
| S084 | 2022-03-14 | 30-day Notice |
| S083 | 2022-01-20 | 30-day Notice |
| S082 | ||
| S081 | 2021-11-17 | 30-day Notice |
| S080 | 2021-11-16 | 30-day Notice |
| S079 | 2021-09-24 | 30-day Notice |
| S078 | 2021-08-24 | 30-day Notice |
| S077 | 2021-06-22 | 30-day Notice |
| S076 | ||
| S075 | 2021-05-07 | 30-day Notice |
| S074 | ||
| S073 | 2021-03-31 | 30-day Notice |
| S072 | 2021-02-26 | 30-day Notice |
| S071 | 2021-02-17 | Normal 180 Day Track No User Fee |
| S070 | 2021-02-04 | 30-day Notice |
| S069 | 2020-11-20 | 30-day Notice |
| S068 | 2020-11-19 | 30-day Notice |
| S067 | 2020-11-09 | 30-day Notice |
| S066 | ||
| S065 | 2020-09-29 | 30-day Notice |
| S064 | 2020-08-07 | 30-day Notice |
| S063 | ||
| S062 | 2020-06-03 | 30-day Notice |
| S061 | 2020-04-24 | 30-day Notice |
| S060 | 2020-03-13 | 30-day Notice |
| S059 | ||
| S058 | ||
| S057 | 2019-11-21 | 30-day Notice |
| S056 | 2019-11-06 | 30-day Notice |
| S055 | ||
| S054 | ||
| S053 | 2019-08-14 | 30-day Notice |
| S052 | 2019-08-12 | 30-day Notice |
| S051 | 2019-07-12 | 30-day Notice |
| S050 | 2019-06-27 | 30-day Notice |
| S049 | 2019-06-11 | 30-day Notice |
| S048 | 2019-06-04 | 30-day Notice |
| S047 | ||
| S046 | 2019-02-01 | 30-day Notice |
| S045 | 2018-11-20 | 30-day Notice |
| S044 | 2018-11-14 | 30-day Notice |
| S043 | 2018-11-13 | Normal 180 Day Track No User Fee |
| S042 | 2018-08-20 | 30-day Notice |
| S041 | 2018-08-01 | 30-day Notice |
| S040 | 2018-06-01 | 30-day Notice |
| S039 | 2018-03-09 | Normal 180 Day Track |
| S038 | 2018-03-01 | 30-day Notice |
| S037 | 2018-01-26 | 30-day Notice |
| S036 | 2017-11-24 | Normal 180 Day Track |
| S035 | 2017-11-20 | 30-day Notice |
| S034 | 2017-08-24 | 30-day Notice |
| S033 | 2017-08-18 | 30-day Notice |
| S032 | 2017-07-28 | Normal 180 Day Track |
| S031 | 2017-05-16 | 30-day Notice |
| S030 | 2017-04-28 | 30-day Notice |
| S029 | 2017-04-11 | 30-day Notice |
| S028 | 2017-03-13 | 30-day Notice |
| S027 | 2016-11-23 | 30-day Notice |
| S026 | 2016-11-22 | 30-day Notice |
| S025 | 2016-11-14 | 30-day Notice |
| S024 | 2016-10-20 | 30-day Notice |
| S023 | 2016-10-17 | 30-day Notice |
| S022 | 2016-09-30 | 30-day Notice |
| S021 | 2016-09-20 | 30-day Notice |
| S020 | 2016-09-07 | 30-day Notice |
| S019 | 2016-08-01 | 30-day Notice |
| S018 | 2016-07-28 | 30-day Notice |
| S017 | 2016-07-25 | 30-day Notice |
| S016 | 2016-07-15 | 30-day Notice |
| S015 | 2016-07-15 | 135 Review Track For 30-day Notice |
| S014 | 2016-05-20 | 30-day Notice |
| S013 | 2016-05-10 | Real-time Process |
| S012 | 2016-04-22 | 30-day Notice |
| S011 | 2016-04-19 | Normal 180 Day Track No User Fee |
| S010 | 2016-04-18 | 30-day Notice |
| S009 | 2016-04-13 | 30-day Notice |
| S008 | 2016-03-09 | 30-day Notice |
| S007 | 2016-02-18 | 30-day Notice |
| S006 | 2016-02-17 | Normal 180 Day Track |
| S005 | 2016-02-04 | 30-day Notice |
| S004 | 2016-01-06 | 30-day Notice |
| S003 | 2015-12-07 | Panel Track |
| S002 | 2015-12-01 | Normal 180 Day Track No User Fee |
| S001 | 2015-11-16 | 30-day Notice |