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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 NumberS033
Date Received06/04/2009
Decision Date07/24/2009
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes including a change to conditional mr compatibility.
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