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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 product family
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 NumberS123
Date Received02/19/2021
Decision Date08/02/2021
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a new ethylene oxide sterilization cycle to be performed at a new sterilization site (Sterigenics US, LLC located at 2400 Airport Road, Santa Teresa, NM)
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