- Device
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S076
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2019-12-18
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modified manufacturing process for the laminated film used in manufacture of the GORE VIATORR TIPS Endoprosthesis and the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion.