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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
Generic NameIliac covered stent, arterial
ApplicantBARD PERIPHERAL VASCULAR, INC.
1625 WEST 3RD ST.
TEMPE, AZ 85281-1740
PMA NumberP160024
Date Received07/21/2016
Decision Date04/24/2017
Product Code PRL 
Docket Number 17M-2594
Notice Date 04/25/2017
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the LifeStream Balloon Expandable Vascular Covered Stent. This device is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesion lengths up to 100 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 
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