Supera Peripheral Stent System Nylon Pouch
FDA premarket approval P120020/S029 · decided 2022-12-20
Approval details
- PMA number
- P120020
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Supera Peripheral Stent System Nylon Pouch
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2022-09-30
- Decision date
- 2022-12-20
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for modification to the packaging pouch.
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