Orsiro Mission Sirolimus Eluting Coronary Stent System
FDA premarket approval P170030/S028 · decided 2023-12-21
Approval details
- PMA number
- P170030
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biotronik AG
- Date received
- 2023-03-31
- Decision date
- 2023-12-21
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- approval for an update to the specification for the maximum post-dilatation diameter for the T6S stent design from 3.5 mm to 4.0 mm
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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 |