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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZENITH RENU AAA ANCILLARY GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCOOK, INC.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS039
Date Received06/23/2011
Decision Date07/17/2012
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFIED LABEL TO INCORPORATE INFORMATION FROM THE POST-APPROVAL STUDY.
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