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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 Iliac Branch Endoprosthesis
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N. North Valley Parkway
Phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS180
Date Received02/23/2021
Decision Date03/25/2021
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
implementation of an FEP formulation change by a sub-tier supplier in the manufacturing of Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device), GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SYSTEM (CMDS Device) and GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Bifurcated Component (IBE IBC Device).
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