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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 NameZENITH AAA ENDOVASCULAR GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK INCORPORATED
PMA NumberP020018
Supplement NumberS042
Date Received02/03/2012
Decision Date04/13/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use (ifu) labeling. The labeling changes involved recommendations to users regarding maintaining hemostasis, use of fluoroscopy and trigger wire release, and an alternative suprarenal deployment sequence.
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