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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 VIATORR TIPS ENDOPROSTHESIS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. GORE & ASSOCIATES, INC.
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085
PMA NumberP040027
Supplement NumberS049
Date Received08/25/2016
Decision Date09/21/2016
Product Code MIR 
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 changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.
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