PMA P040027S048
- Device
- GORE VIATORR TIPS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S048
- Product code
- MIR
- Decision date
- 2016-08-18
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Approval for addition of GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion to the GORE® VIATORR® TIPS Endoprosthesis product line.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S048
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2016-08-18
- Decision code
- APPR
- Date received
- 2016-02-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion to the GORE® VIATORR® TIPS Endoprosthesis product line.