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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 NameFLAIR ENDOVASCULAR STENT GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoprosthesis
ApplicantC.R. BARD, INC.
PMA NumberP060002
Supplement NumberS030
Date Received03/29/2013
Decision Date04/22/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implement a new system for printing product labels for the device.
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