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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 Dissection Endovascular System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantWilliam Cook Europe Aps
Sandet 6, Dk-4632
Bjaeverskov 
PMA NumberP180001
Supplement NumberS005
Date Received05/05/2022
Decision Date06/02/2022
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 for updating the Instructions for Use to report the theoretical (i.e., calculated) maximum length for the Zenith Dissection Endovascular Stent.
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