- Device
- GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S085
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2021-03-04
- Decision code
- OK30
- Date received
- 2021-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a change from a manual inspection method to an automated inspection method for in-process verification of GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.