Innova Vascular Self-Expanding Stent with Delivery System
FDA premarket approval P140028/S079 · decided 2024-03-13
Approval details
- PMA number
- P140028
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Innova Vascular Self-Expanding Stent with Delivery System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-02-13
- Decision date
- 2024-03-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- addition of parametric release for the BSC856 ethylene oxide sterilization cycle at the BSC Coventry, RI Facility
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