To replace the vacuum purge system with a positive pressure purge system
| Device | Eluvia Drug-Eluting Vascular Stent System |
| Classification Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Generic Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Applicant | Boston Scientific Corp. |
| Date Received | 2019-08-27 |
| Decision Date | 2019-09-06 |
| PMA | P180011 |
| Supplement | S010 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180011 | | Original Filing |
| S051 |
2022-10-18 |
30-day Notice |
| S050 |
2022-08-08 |
30-day Notice |
| S049 |
2022-04-07 |
30-day Notice |
| S048 |
2021-11-15 |
30-day Notice |
| S047 |
2021-10-04 |
30-day Notice |
| S046 | | |
| S045 |
2021-08-30 |
30-day Notice |
| S044 | | |
| S043 |
2021-07-09 |
30-day Notice |
| S042 |
2021-04-13 |
30-day Notice |
| S041 |
2021-02-01 |
30-day Notice |
| 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 |
NIH GUDID Devices