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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
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCook Medical Incorporated
Sandet 6
Bjaeverskov 4632
PMA NumberP140016
Supplement NumberS015
Date Received06/26/2025
Decision Date09/18/2025
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in coating for the delivery system of the Zenith Alpha 2 Thoracic Endovascular Graft
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