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.
Changes to the stability study parameters and the introduction of a leak test method for packaging integrity testing
| Device | ORSIRO Sirolimus Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Biotronik, Inc |
| Date Received | 2021-07-02 |
| Decision Date | 2021-07-28 |
| PMA | P170030 |
| Supplement | S018 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170030 | Original Filing | |
| S026 | 2022-07-07 | 30-day Notice |
| S025 | ||
| S024 | 2022-06-21 | 30-day Notice |
| S023 | ||
| S022 | ||
| S021 | 2022-01-31 | 30-day Notice |
| S020 | 2021-11-09 | 30-day Notice |
| S019 | ||
| S018 | 2021-07-02 | 30-day Notice |
| S017 | 2021-06-14 | 30-day Notice |
| S016 | 2021-04-08 | 30-day Notice |
| S015 | 2021-03-25 | 30-day Notice |
| S014 | 2021-01-19 | 30-day Notice |
| S013 | 2020-10-16 | 30-day Notice |
| S012 | 2020-10-16 | 30-day Notice |
| S011 | 2020-10-02 | Normal 180 Day Track No User Fee |
| S010 | 2020-09-21 | 30-day Notice |
| S009 | ||
| S008 | 2020-07-22 | 30-day Notice |
| S007 | ||
| S006 | 2020-06-02 | 30-day Notice |
| S005 | 2019-11-04 | 30-day Notice |
| S004 | 2019-09-27 | 30-day Notice |
| S003 | 2019-04-17 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 |