Supera Peripheral Stent System
FDA premarket approval P120020/S034 · decided 2025-12-09
Approval details
- PMA number
- P120020
- Supplement
- S034
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Supera Peripheral Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2025-05-12
- Decision date
- 2025-12-09
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- approval for a manufacturing site located at Synergy Health AST, SRL, B13.1 Street 4, Avenue 1, Coyol Free Zone, Coyol, Alajuela, 20102, Costa Rica for sterilization.
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