Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
FDA premarket approval P170030/S022 · decided 2022-08-31
Approval details
- PMA number
- P170030
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biotronik AG
- Date received
- 2022-03-04
- Decision date
- 2022-08-31
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for the PMA Post-Approval Study Labeling Update for the Orsiro and Orsiro Mission Siolimus Eluting Coronary Stent Systems.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |