PMA P040027S003
- Device
- GORE VIATORR TIPS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S003
- Product code
- MIR
- Decision date
- 2006-10-25
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE INSTRUCTION FOR USE.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S003
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2006-10-25
- Decision code
- APPR
- Date received
- 2006-10-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE INSTRUCTION FOR USE.