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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 AND LIFESTENT XL VASCULAR STENT SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP070014
Supplement NumberS001
Date Received06/02/2009
Decision Date07/30/2009
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE NAME AND PACKAGE LABEL FOR THE LIFESTENTVASCULAR STENT SYSTEMS. SPECIFICALLY, THE WORD "FLEXSTAR" WILL BE REMOVED FROM THE TRADE NAMEAND "& BILIARY" WILL BE ADDED TO THE DEVICE PACKAGE LABELS TO REFLECT THE CLEARED BILIARY INDICATION FOR THIS DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTENTVASCULAR STENT SYSTEM AND LIFESTENT XL VASCULAR STENT SYSTEM AND IS INDICATED FORIMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF DE-NOVO OR RESTENOTIC LESION IN THE NATIVESFA AND PROXIMAL POPLITEAL ARTERIES.
Post-Approval StudyShow Report Schedule and Study Progress
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