Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System
FDA premarket approval P170030/S023 · decided 2023-03-22
Approval details
- PMA number
- P170030
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biotronik AG
- Date received
- 2022-05-12
- Decision date
- 2023-03-22
- Days to decision
- 314 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 allowed post-dilatation diameter for the 3.5 mm and 4.0 mm stent designs from 4.5 mm to 5.0 mm and updates to the dual antiplatelet therapy recommendation in the Instructions for Use for both the Orsiro and Orsiro Mission Stent Systems.
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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 |