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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 RENU AAA ANCILLARY GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK INCORPORATED
PMA NumberP020018
Supplement NumberS039
Date Received06/23/2011
Decision Date07/17/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified label to incorporate information from the post-approval study.
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