PMA P040027S088
- Device
- GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- PMA number
- P040027
- Supplement
- S088
- Product code
- MIR
- Decision date
- 2021-09-24
- Generic name
- Shunt, Portosystemic, Endoprosthesis
- Approval order statement
- Approval Of A Replacement Zipper Braider Machine
Current openFDA PMA Record
- Device
- GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S088
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement zipper braider machine.