SUPERA PERIPHERAL STENT SYSTEM
FDA premarket approval P120020 · decided 2014-03-28
Approval details
- PMA number
- P120020
- Trade name
- SUPERA PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2012-11-16
- Decision date
- 2014-03-28
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE SUPERA® PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY, WITH REFERENCE VESSEL DIAMETERS OF 4.0 TO 6.5 MM, AND LESION LENGTHS UP TO 140 MM.
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