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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 NumberS010
Date Received03/29/2024
Decision Date09/25/2024
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes associated with introduction systems for proximal and distal components as well as the distal extension of the Zenith Alpha Thoracic Endovascular Graft System
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