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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameLIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Date Received05/25/2007
Decision Date02/13/2009
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 09M-0127
Notice Date 03/10/2009
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S022 S023 S024 S026 
S027 S028 S029 S030 S031 S032 
S033 S034 S035 S036 S038 
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