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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 NumberS039
Date Received06/14/2013
Decision Date07/12/2013
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ACCEPTANCE FOR AN ALTERNATE SUB-SUPPLIER OF TACKIFIER RESIN TO THE APPROVED SUPPLIER OF STERILE BARRIER POUCHES FOR THE BARD® LIFESTENT® VASCULAR STENT SYSTEMS.
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