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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® 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 NumberS134
Date Received02/22/2023
Decision Date03/08/2023
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  
Specification update to allow consistency of the manufacturing process across device sizes for the GORE TAG Thoracic Endoprosthesis and the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System.
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