BARD LIFESTENT VASCULAR STENT SYSTEM
FDA premarket approval P070014/S037 · decided 2016-05-31
Approval details
- PMA number
- P070014
- Supplement
- S037
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BARD LIFESTENT VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-12-28
- Decision date
- 2016-05-31
- Days to decision
- 1250 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for the Bard® LifeStent® Vascular Stent System. The Bard® LifeStent® Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 to 6.5 mm.
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