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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.
 
DeviceBARD FLAIR ENDOVASCULAR STENT GRAFT
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantBard Peripheral Vascular
1625 W Third St.
Tempe, AZ 85281
PMA NumberP060002
Supplement NumberS014
Date Received07/28/2010
Decision Date08/13/2010
Withdrawal Date09/12/2022
Product Code PFV 
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  
REVISED FORMULATION FOR THE ADHESIVE USED DURING MANUFACTURING.
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