PMA P040027S067
- Device
- GORE VIATORR TIPS Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S067
- Product code
- MIR
- Decision date
- 2018-10-11
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Implementation of an additional resin blend pelletizer that is used in the manufacturing process of base tube device components.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S067
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2018-10-11
- Decision code
- OK30
- Date received
- 2018-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an additional resin blend pelletizer that is used in the manufacturing process of base tube device components.