INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
FDA premarket approval P140028 · decided 2015-07-21
Approval details
- PMA number
- P140028
- Trade name
- INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-12-10
- Decision date
- 2015-07-21
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR: THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE VESSEL DIAMETERS FROM 4.0 MM TO 7.0 MM AND LESION LENGTHS UP TO 190 MM.
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