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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFLAIR ENDOVASCULAR STENT GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoprosthesis
ApplicantBARD PERIPHERAL VASCULAR
PMA NumberP060002
Date Received01/17/2006
Decision Date07/23/2007
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 07M-0298
Notice Date 08/01/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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