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.
Updates to the software for sterilization aeration at the bsc coventry, rhode island facility
| Device | Eluvia Drug-Eluting Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Applicant | Boston Scientific Corp. |
| Date Received | 2020-12-03 |
| Decision Date | 2020-12-17 |
| PMA | P180011 |
| Supplement | S040 |
| Product Code | NIU |
| 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 Corp. one Scimed Place maple Grove, MN 55311 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180011 | Original Filing | |
| S040 | 2020-12-03 | 30-day Notice |
| S039 | 2020-11-20 | 30-day Notice |
| S038 | 2020-11-09 | 30-day Notice |
| S037 | 2020-08-21 | 30-day Notice |
| S036 | ||
| S035 | 2020-07-14 | 30-day Notice |
| S034 | ||
| S033 | 2020-06-10 | 30-day Notice |
| S032 | 2020-06-05 | 30-day Notice |
| S031 | 2020-04-21 | 30-day Notice |
| S030 | 2020-03-27 | 30-day Notice |
| S029 | 2020-03-23 | 30-day Notice |
| S028 | ||
| S027 | 2020-02-07 | 30-day Notice |
| S026 | 2020-01-27 | 30-day Notice |
| S025 | ||
| S024 | ||
| S023 | 2020-01-15 | 30-day Notice |
| S022 | 2020-01-08 | 30-day Notice |
| S021 | 2019-12-09 | 30-day Notice |
| S020 | 2019-11-21 | 30-day Notice |
| S019 | 2019-11-18 | 30-day Notice |
| S018 | 2019-11-15 | 30-day Notice |
| S017 | 2019-11-13 | 30-day Notice |
| S016 | 2019-09-30 | 30-day Notice |
| S015 | 2019-09-16 | 30-day Notice |
| S014 | 2019-08-14 | 30-day Notice |
| S013 | ||
| S012 | 2019-09-12 | 30-day Notice |
| S011 | 2019-08-30 | Special (immediate Track) |
| S010 | 2019-08-27 | 30-day Notice |
| S009 | 2019-06-27 | 30-day Notice |
| S008 | 2019-05-21 | 30-day Notice |
| S007 | 2019-05-06 | 30-day Notice |
| S006 | ||
| S005 | 2019-03-01 | 30-day Notice |
| S004 | ||
| S003 | 2018-11-21 | 30-day Notice |
| S002 | 2018-11-14 | 30-day Notice |
| S001 | 2018-11-06 | 30-day Notice |