PMA P040027S007
- Device
- GORE VIATORR TIPS ENDOPROTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S007
- Product code
- MIR
- Decision date
- 2008-04-11
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S007
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2008-04-11
- Decision code
- APPR
- Date received
- 2007-09-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.