PMA P040027S054

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S054
Product code: MIR
Decision date: 2017-03-22
Classification: Shunt, Portosystemic, Endoprosthesis
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: Approval for the following modifications to the Instructions for Use (IFU): 1) to include the GORE® TIPS Sheath as an additional recommended accessory; and 2) to revise the post-placement management instructions.

Current openFDA PMA Record#

Device: GORE VIATORR TIPS ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S054
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2017-03-22
Decision code: APPR
Date received: 2017-01-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following modifications to the Instructions for Use (IFU): 1) to include the GORE® TIPS Sheath as an additional recommended accessory; and 2) to revise the post-placement management instructions.