PMA P040027S070
- Device
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S070
- Product code
- MIR
- Decision date
- 2019-03-21
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Relocate the manufacturing equipment for a delivery system component.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S070
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2019-03-21
- Decision code
- OK30
- Date received
- 2019-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate the manufacturing equipment for a delivery system component.