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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 NumberS012
Date Received04/05/2024
Decision Date04/29/2024
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
use of an alternative suture in manufacturing of the Zenith® Fenestrated AAA Endovascular Graft, Zenith Alpha™ Thoracic Endovascular Graft, and Zenith® Dissection Endovascular System
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