PMA P040027S046
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S046
- Product code
- MIR
- Decision date
- 2015-12-15
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- AN ALTERNATE MANUFACTURING LOCATION FOR THE GRAFT COMPONENT AND ALTERNATE LOCATION FOR COMPONENT DESTRUCTIVE TESTING.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S046
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2015-12-15
- Decision code
- OK30
- Date received
- 2015-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN ALTERNATE MANUFACTURING LOCATION FOR THE GRAFT COMPONENT AND ALTERNATE LOCATION FOR COMPONENT DESTRUCTIVE TESTING.