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.
Approval of the boston scientific maple grove site as a stent component manufacturing site for the innova stent.
| Device | INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2016-03-14 |
| Decision Date | 2016-05-11 |
| PMA | P140028 |
| Supplement | S010 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140028 | Original Filing | |
| S075 | 2022-10-18 | 30-day Notice |
| S074 | 2022-08-08 | 30-day Notice |
| S073 | 2022-04-07 | 30-day Notice |
| S072 | 2021-11-15 | 30-day Notice |
| S071 | 2021-10-04 | 30-day Notice |
| S070 | ||
| S069 | 2021-08-30 | 30-day Notice |
| S068 | ||
| S067 | 2021-02-01 | 30-day Notice |
| S066 | 2020-12-03 | 30-day Notice |
| S065 | 2020-11-20 | 30-day Notice |
| S064 | 2020-08-21 | 30-day Notice |
| S063 | ||
| S062 | 2020-07-14 | 30-day Notice |
| S061 | ||
| S060 | 2020-06-05 | 30-day Notice |
| S059 | 2020-03-27 | 30-day Notice |
| S058 | 2020-03-23 | 30-day Notice |
| S057 | 2020-03-16 | 30-day Notice |
| S056 | ||
| S055 | ||
| S054 | 2020-01-27 | 30-day Notice |
| S053 | ||
| S052 | 2019-12-09 | 30-day Notice |
| S051 | ||
| S050 | ||
| S049 | 2019-11-18 | 30-day Notice |
| S048 | 2019-11-15 | 30-day Notice |
| S047 | 2019-11-13 | 30-day Notice |
| S046 | 2019-09-30 | 30-day Notice |
| S045 | 2019-09-16 | 30-day Notice |
| S044 | ||
| S043 | 2019-08-27 | 30-day Notice |
| S042 | ||
| S041 | 2019-06-27 | 30-day Notice |
| S040 | 2019-05-21 | 30-day Notice |
| S039 | 2019-05-06 | 30-day Notice |
| S038 | 2019-02-04 | 30-day Notice |
| S037 | 2019-01-28 | 30-day Notice |
| S036 | 2018-12-17 | Special (immediate Track) |
| S035 | 2018-11-21 | 30-day Notice |
| S034 | 2018-11-14 | 30-day Notice |
| S033 | 2018-09-19 | 30-day Notice |
| S032 | 2018-06-01 | 30-day Notice |
| S031 | ||
| S030 | 2017-11-20 | 30-day Notice |
| S029 | 2017-10-12 | 30-day Notice |
| S028 | 2017-08-09 | 30-day Notice |
| S027 | 2017-05-30 | 30-day Notice |
| S026 | 2017-05-16 | 30-day Notice |
| S025 | 2017-04-28 | 30-day Notice |
| S024 | 2017-01-25 | 30-day Notice |
| S023 | 2016-11-22 | 30-day Notice |
| S022 | 2016-11-22 | 30-day Notice |
| S021 | 2016-11-21 | Normal 180 Day Track No User Fee |
| S020 | 2016-11-02 | 30-day Notice |
| S019 | 2016-10-03 | 30-day Notice |
| S018 | 2016-08-19 | 30-day Notice |
| S017 | 2016-08-17 | 30-day Notice |
| S016 | 2016-08-05 | 30-day Notice |
| S015 | 2016-07-13 | 30-day Notice |
| S014 | 2016-05-03 | 30-day Notice |
| S013 | 2016-04-29 | 30-day Notice |
| S012 | 2016-04-11 | 30-day Notice |
| S011 | 2016-03-21 | 30-day Notice |
| S010 | 2016-03-14 | Normal 180 Day Track No User Fee |
| S009 | 2016-03-11 | 30-day Notice |
| S008 | 2016-03-02 | 30-day Notice |
| S007 | 2016-02-18 | 30-day Notice |
| S006 | 2015-11-06 | 30-day Notice |
| S005 | 2015-10-19 | 30-day Notice |
| S004 | 2015-10-13 | 30-day Notice |
| S003 | 2015-09-28 | 30-day Notice |
| S002 | 2015-09-09 | 30-day Notice |
| S001 | 2015-08-19 | Normal 180 Day Track No User Fee |