BARD LIFESTENT VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S022 · decided 2011-09-16
Approval details
- PMA number
- P070014
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BARD LIFESTENT VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-03-10
- Decision date
- 2011-09-16
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE ADDITION OF A 200 MM LENGTH STENT AND A NEW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BARD LIFESTENT SOLO VASCULAR STENT SYSTEM AND IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DENOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 - 6.5 MM.
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