SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S004 · decided 2014-07-10
Approval details
- PMA number
- P120020
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2014-05-27
- Decision date
- 2014-07-10
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR IMPLEMENTATION OF A SEMI-AUTOMATED PASSIVATION PROCESS AND A CHANGE TO THE PASSIVATION OF STENT COUPLINGS BY AN ALTERNATE VENDOR.
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