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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® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore and Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP200030
Supplement NumberS022
Date Received07/31/2025
Decision Date08/29/2025
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  
a manufacturing facility move for a supplier of delivery system components for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) and GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
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