Innova Vascular Self-Expanding Stent with Delivery System
FDA premarket approval P140028/S055 · decided 2020-05-05
Approval details
- PMA number
- P140028
- Supplement
- S055
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2020-01-30
- Decision date
- 2020-05-05
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the addition of a manufacturing site located at Synergy Health AST, SRL, in Alajuela, Costa Rica to perform contract sterilization.
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