Supera Peripheral Stent System
FDA premarket approval P120020/S026 · decided 2021-05-12
Approval details
- PMA number
- P120020
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Supera Peripheral Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2021-01-05
- Decision date
- 2021-05-12
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for adding new device sizes to the product line.
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