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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.
 
DeviceFLAIR ENDOVASCULAR STENT GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
BARD PERIPHERAL VASCULAR
1625 w. third st
tempe, AZ 85281
PMA NumberP060002
Supplement NumberS029
Date Received02/19/2013
Decision Date03/15/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional laser cutting system as part of the manufacturing process for the flair® endovascular stent graft.
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