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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBARD FLAIR ENDOVASCULAR STENT GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoprosthesis
ApplicantC.R. BARD, INC.
PMA NumberP060002
Supplement NumberS011
Date Received03/19/2010
Decision Date04/16/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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