PMA P040027S096

Device: GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S096
Product code: MIR
Decision date: 2024-02-06
Classification: Cardiovascular
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: revisions to the sampling plan used in the Quality Control testing of the GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion

Current openFDA PMA Record

Device: GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040027
Supplement: S096
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2024-02-06
Decision code: OK30
Date received: 2024-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: revisions to the sampling plan used in the Quality Control testing of the GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion