SUPERA PERIPHERAL STENT SYSTEM (SUPERB)
FDA premarket approval P120020/S002 · decided 2014-10-20
Approval details
- PMA number
- P120020
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SUPERA PERIPHERAL STENT SYSTEM (SUPERB)
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2014-04-08
- Decision date
- 2014-10-20
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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