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 | SYNERGY Drug Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP150003 Supplement NumberS085 Date Received04/07/2022 Decision Date05/06/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-05-06 |
| PMA | P150003 |
| Supplement | S085 |
| 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 PMA NumberP150003 Supplement NumberS085 Date Received04/07/2022 Decision Date05/06/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Process Devices Using The Reduced EtO S756 Sterilization Cycle At The BSC Coventry Rhode Island, BSC Galway Ireland, And Steris Tullamore Ireland Facilities |
| 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 |