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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Supplement NumberS010
Date Received04/05/2010
Decision Date12/23/2010
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 11M-0039
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00673985
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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