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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.
 
DeviceGORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Generic NameEndovascular system for treatment of thoracoabdominal and pararenal aortic lesions
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP230023
Supplement NumberS004
Date Received09/30/2024
Decision Date12/23/2024
Product Code QZK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of color additives to the secondary sleeve deployment line, primary sleeve deployment line and sleeve attachment fibers of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
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