- Device
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S078
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2020-03-04
- Decision code
- OK30
- Date received
- 2020-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a camera-based error-proofing mechanism to a machine that manufactures a component of the delivery system.