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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.
 
DeviceConformable GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
3450 Kiltie Ln.
P.O. Box 2400
Flagstaff, AZ 86003
PMA NumberP040043
Supplement NumberS138
Date Received06/03/2024
Decision Date07/03/2024
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the addition of new equipment to the stent winding process for the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
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