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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 NumberS001
Date Received02/08/2024
Decision Date03/22/2024
Product Code QZK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230023.
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