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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 NumberS001
Date Received06/28/2017
Decision Date07/28/2017
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to remove blunt thoracic aortic injury from the indications for use and remove references to the smaller diameter grafts that have been removed from the market.
LabelingLabeling
Labeling Part 2
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