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.
Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.
| 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 | 2019-06-27 |
| Decision Date | 2019-07-25 |
| PMA | P140028 |
| Supplement | S041 |
| Product Code | NIP |
| 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 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 |