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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 SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
PMA NumberP070014
Supplement NumberS038
Date Received03/29/2013
Decision Date04/22/2013
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENT A NEW SYSTEM FOR PRINTING PRODUCT LABELS FOR THE DEVICE.
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