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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 NumberS011
Date Received03/19/2010
Decision Date04/16/2010
Withdrawal Date 09/12/2022
Product Code PFV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE TO INCLUDE LANGUAGE TO IMPROVE THE SAFETY IN USE OF THE DEVICE, PREDOMINANTLY WITH RESPECT TO THE POTENTIAL FOR DEVICE MIGRATIONS.
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