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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 NumberS009
Date Received11/17/2023
Decision Date12/15/2023
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
change in the PTFE wire coating of the nitinol release wires used in the introduction system of the Zenith Alpha Thoracic Endovascular Graft and Zenith Dissection Endovascular System
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