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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 NumberS013
Date Received06/21/2024
Decision Date07/19/2024
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  
the move of a sub-supplier (Johnson Matthey) manufacturing facility site from USA to Mexico
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