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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® Conformable AAA Endoprosthesis (EXCC)
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore and Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP200030
Supplement NumberS005
Date Received10/29/2021
Decision Date11/22/2021
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  
Error-proofing software updates to the bonding machine for bonding the leading tip of the Gore EXCC Trunk-ipsilateral device.
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