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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.
 
DeviceFLAIR 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 NumberS034
Date Received02/14/2014
Decision Date08/13/2014
Withdrawal Date09/12/2022
Product Code PFV 
Advisory Committee Cardiovascular
Clinical TrialsNCT00677235
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA).
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