SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S003 · decided 2014-11-07
Approval details
- PMA number
- P120020
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUPERA PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2014-05-22
- Decision date
- 2014-11-07
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A CHANGE TO THE COLORS INCLUDED IN THE 6FR AND 7FR DELIVERY SYSTEMS MANUFACTURED AT THE CURRENT SITE IN WEBSTER, TEXAS.
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