Orsiro Mission Sirolimus Eluting Coronary Stent System
FDA premarket approval P170030/S007 · decided 2021-06-24
Approval details
- PMA number
- P170030
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biotronik AG
- Date received
- 2020-07-08
- Decision date
- 2021-06-24
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for a modified stent delivery system containing multiple material and design changes including an updated hub/luer connector, packaging changes to accommodate the modified stent delivery system, and a change to the stent crimping manufacturing process.
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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 |