PMA P040027S010
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S010
- Product code
- MIR
- Decision date
- 2008-05-29
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S010
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2008-05-29
- Decision code
- APPR
- Date received
- 2008-01-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.