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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 Fenestrated AAA Endovascular Graft
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS060
Date Received07/23/2021
Decision Date01/20/2022
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00875563
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the labeling updates for the post-approval study (PAS) protocol.
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