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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® Iliac Branch Endoprosthesis
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP020004
Supplement NumberS203
Date Received08/11/2025
Decision Date09/09/2025
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of an additional primary supplier of radiopaque markers used in the GORE® EXCLUDER® Iliac Branch Endoprosthesis, Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, and GORE® TAG® Thoracic Branch Endoprosthesis
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