SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S014 · decided 2017-02-01
Approval details
- PMA number
- P120020
- Supplement
- S014
- 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
- 2016-08-30
- Decision date
- 2017-02-01
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for the removal of the in-process dimensional inspection of the nitinol wire diameter before and after the passivation process.
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