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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 NumberS027
Date Received07/20/2012
Decision Date01/16/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a line extension of the flair® endovascular stent graft to add a 70 mm length. In addition, there are three additional minor changes. These included: manufacturing core modification, delivery system flaring mandrel modification, and chamfer of guiding tube modification.
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