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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 and 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 NumberS121
Date Received01/13/2021
Decision Date01/22/2021
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  
Computer hardware and software upgrades for bacterial endotoxin testing equipment.
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