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.
| Device | ELUVIA Drug-Eluting Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS051 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIU Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-18 |
| Decision Date | 2022-11-07 |
| PMA | P180011 |
| Supplement | S051 |
| 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 PMA NumberP180011 Supplement NumberS051 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIU Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement approval To Move Portions Of The Component Level Manufacturing Into A New Building At The Maple Grove, Minnesota BSC Site |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729876731 | P180011 | 000 |
| 08714729876595 | P180011 | 000 |
| 08714729876588 | P180011 | 000 |
| 08714729876571 | P180011 | 000 |
| 08714729876557 | P180011 | 000 |
| 08714729876540 | P180011 | 000 |
| 08714729876533 | P180011 | 000 |
| 08714729876526 | P180011 | 000 |
| 08714729876519 | P180011 | 000 |
| 08714729876601 | P180011 | 000 |
| 08714729876618 | P180011 | 000 |
| 08714729876632 | P180011 | 000 |
| 08714729876724 | P180011 | 000 |
| 08714729876717 | P180011 | 000 |
| 08714729876700 | P180011 | 000 |
| 08714729876694 | P180011 | 000 |
| 08714729876670 | P180011 | 000 |
| 08714729876663 | P180011 | 000 |
| 08714729876656 | P180011 | 000 |
| 08714729876649 | P180011 | 000 |
| 08714729876748 | P180011 | 046 |
| 08714729876687 | P180011 | 046 |
| 08714729876625 | P180011 | 046 |
| 08714729876564 | P180011 | 046 |