PMA P040027S099

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S099
Product code: MIR
Decision date: 2025-10-27
Classification: Cardiovascular
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: approval for a modification to the controlled expansion sleeve that allows the device to have a 6-10 mm adjustable diameter range (as opposed to the existing 8-10 mm diameter range)

Current openFDA PMA Record

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S099
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2025-10-27
Decision code: APPR
Date received: 2025-04-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a modification to the controlled expansion sleeve that allows the device to have a 6-10 mm adjustable diameter range (as opposed to the existing 8-10 mm diameter range)