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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 W. 3rd St.
Tempe, AZ 85281
PMA NumberP070014
Supplement NumberS032
Date Received04/06/2012
Decision Date05/25/2012
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MINOR CHANGES TO THE DIVING SHEATH WITH PULL WIRE COMPONENT OF THE DELIVERY SYSTEM.
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