Approval of the orsiro sirolimus eluting coronary stent system. This device is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-st elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2. 25 mm to 4. 0 mm and a lesion length of < 36 mm.
| Device | ORSIRO Sirolimus Eluting Coronary Stent System |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Biotronik, Inc |
| Date Received | 2017-09-27 |
| Decision Date | 2019-02-22 |
| Notice Date | 2019-02-25 |
| PMA | P170030 |
| Supplement | S |
| Product Code | NIQ |
| Docket Number | 19M-0885 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |