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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIFESTENT VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP070014
Supplement NumberS047
Date Received10/27/2014
Decision Date04/23/2015
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DELIVERY SYSTEM MODIFICATIONS.
Post-Approval StudyShow Report Schedule and Study Progress
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