SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020/S009 · decided 2015-07-24
Approval details
- PMA number
- P120020
- Supplement
- S009
- Supplement type
- Real-Time Process
- 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
- 2015-04-28
- Decision date
- 2015-07-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR NEW INTERMEDIATE PRODUCT SIZES.APPROVAL FOR NEW INTERMEDIATE PRODUCT SIZES.
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