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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 SOLO VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP070014
Supplement NumberS026
Date Received09/26/2011
Decision Date10/26/2011
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PRODUCT LABELING, PREDOMINANTLY WITH RESPECT TO IMPROVING THE SAFE USE OF THE DEVICE BY MODIFYING THE STENT DEPLOYMENT PROCEDURE LANGUAGE IN THE INSTRUCTIONS FOR USE, AS WELL AS ADDING NEW SYMBOLS TO THE LABELING.
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