SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S013 · decided 2016-07-13
Approval details
- PMA number
- P120020
- Supplement
- S013
- 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
- 2016-05-09
- Decision date
- 2016-07-13
- Days to decision
- 65 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 Sterigenics Costa Rica.
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