PMA P040027S095

Device: Gore Viatorr TIPS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S095
Product code: MIR
Decision date: 2024-02-07
Classification: Cardiovascular
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
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.

Current openFDA PMA Record

Device: Gore Viatorr TIPS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S095
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2024-02-07
Decision code: APPR
Date received: 2024-01-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.