SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
FDA premarket approval P120002 · decided 2012-11-07
Approval details
- PMA number
- P120002
- Trade name
- SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2012-02-03
- Decision date
- 2012-11-07
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE S.M.A.R.T. CONTROL AND S.M.A.R.T. VASCULAR STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USE TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESION(S) OF THE SUPERFICIAL FEMORAL ARTERY AND/OR PROXIMAL POPLITEAL ARTERY WITH TOTAL LENGTH UP TO 150 MM AND WITH A REFERENCE VESSEL DIAMETER RANGING FROM 4 MM TO 7 MM.
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