- Device
- Gore Viatorr Tips Endoprosthesis and Gore Viatorr Tips Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S077
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2020-01-29
- Decision code
- OK30
- Date received
- 2020-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of manufacturing to a newly constructed cleanroom within the same Phoenix facility.