Supera Peripheral Stent System
FDA premarket approval P120020/S033 · decided 2025-03-09
Approval details
- PMA number
- P120020
- Supplement
- S033
- 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
- 2024-10-11
- Decision date
- 2025-03-09
- Days to decision
- 149 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 Isomedix Operations, Inc., 43425 Business Park Drive, Temecula, CA 92590 for sterilization
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