PMA P040027
- Device
- GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS092 Date Received07/25/2022 Decision Date08/24/2022 Product Code MIR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P040027
- Supplement
- S092
- Product code
- MIR
- Decision date
- 2022-08-24
- Generic name
- Shunt, Portosystemic, Endoprosthesis
Current openFDA PMA Record
- Device
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S099
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2025-10-27
- Decision code
- APPR
- Date received
- 2025-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a modification to the controlled expansion sleeve that allows the device to have a 6-10 mm adjustable diameter range (as opposed to the existing 8-10 mm diameter range)