PMA P040027S061
- Device
- Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S061
- Product code
- MIR
- Decision date
- 2018-05-24
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Alternate test lab for impurities testing.
Current openFDA PMA Record#
- Device
- Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S061
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2018-05-24
- Decision code
- OK30
- Date received
- 2018-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate test lab for impurities testing.