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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 Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCook Medical Incorporated
Sandet 6
Bjaeverskov 4632
PMA NumberP140016
Supplement NumberS017
Date Received04/23/2026
Decision Date05/21/2026
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a new supplier for a component of delivery systems of the Zenith (Flex) AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, Zenith Alpha & Alpha2 Thoracic Endovascular Graft, Zenith Dissection Endovascular System
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