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.
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170030
| Device | ORSIRO Sirolimus Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Biotronik, Inc |
| Date Received | 2020-10-02 |
| Decision Date | 2020-10-30 |
| PMA | P170030 |
| Supplement | S011 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |