SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S011 · decided 2016-01-22
Approval details
- PMA number
- P120020
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUPERA PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2015-08-10
- Decision date
- 2016-01-22
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
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