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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received01/17/2006
Decision Date07/23/2007
Withdrawal Date 09/12/2022
Product Code PFV 
Docket Number 07M-0298
Notice Date 08/01/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FLAIR ENDOVASCULAR STENT GRAFT. THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF STENOSES AT THE VENOUS ANASTOMOSIS OF EPTFE OR OTHER SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S038 S039 
S040 
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