- Device
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S075
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2019-12-06
- Decision code
- OK30
- Date received
- 2019-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for alternate manufacturing equipment as well as the changes this equipment introduces into the stent winding and heat treatment process for the GORE VIATORR TIPS Endoprosthesis and the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion