LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S010 · decided 2010-12-23
Approval details
- PMA number
- P070014
- Supplement
- S010
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2010-03-10
- Decision date
- 2010-12-23
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS. THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS ARE INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO 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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