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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 NumberS025
Date Received04/02/2012
Decision Date04/27/2012
Withdrawal Date 09/12/2022
Product Code PFV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
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