PMA P040027S094
- Device
- GORE® VIATORR® TIPS Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S094
- Product code
- MIR
- Decision date
- 2023-12-08
- Classification
- Cardiovascular
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- addition of a new manufacturing station for the VIATORR TIPS Endoprosthesis
Current openFDA PMA Record
- Device
- GORE® VIATORR® TIPS Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S094
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2023-12-08
- Decision code
- OK30
- Date received
- 2023-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a new manufacturing station for the VIATORR TIPS Endoprosthesis