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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 and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. GORE & ASSOCIATES, INC.
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085
PMA NumberP040027
Supplement NumberS075
Date Received10/25/2019
Decision Date12/06/2019
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  
approval for alternate manufacturing equipment as well as the changes this equipment introduces into the stent winding and heat treatment process for the GORE VIATORR TIPS Endoprosthesis and the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
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