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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
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP040027
Supplement NumberS095
Date Received01/08/2024
Decision Date02/07/2024
Product Code MIR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for updates to the Instructions for Use (IFU) of the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion, including the following: • clarifications to the Warnings and Precautions section;• changes made to comply with the requirements of ISO 14971:2019-Application of risk management to medical devices; • changes made to comply with the 2023 FDA guidance on ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’.
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