Orsiro Mission Sirolimus Eluting Coronary Stent System
FDA premarket approval P170030/S051 · decided 2025-04-11
Approval details
- PMA number
- P170030
- Supplement
- S051
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biotronik AG
- Date received
- 2025-01-28
- Decision date
- 2025-04-11
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- the introduction of an additional wire position control and movability check during the guidewire exit port (GEP) welding and cutting manufacturing steps for the PK Papyrus Covered Coronary Stent System and the Orsiro Mission Sirolimus Eluting Coronary Stent System
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |