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 for modifications to the mr conditional labeling.
| Device | Innova Vascular Self-Expanding Stent System |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2018-12-17 |
| Decision Date | 2019-01-10 |
| PMA | P140028 |
| Supplement | S036 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |