PMA P040027S098

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S098
Product code: MIR
Decision date: 2025-04-09
Classification: Cardiovascular
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: approval for a clarification to the indications for use statement for the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

Current openFDA PMA Record

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S098
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2025-04-09
Decision code: APPR
Date received: 2025-01-10
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a clarification to the indications for use statement for the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion