LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
FDA premarket approval P070014 · decided 2009-02-13
Approval details
- PMA number
- P070014
- Trade name
- LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2007-05-25
- Decision date
- 2009-02-13
- Days to decision
- 630 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE LIFESTENT FLEXSTAR AND FLEXSTAR XL VASCULAR STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 160 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.00 - 6.5 MM.
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