PMA P040027S090
- Device
- GORE® VIATORR® TIPS Endoprosthesis
- Applicant
- W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS090 Date Received01/20/2022 Decision Date02/22/2022 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
- S090
- Product code
- MIR
- Decision date
- 2022-02-22
- Generic name
- Shunt, Portosystemic, Endoprosthesis
Current openFDA PMA Record
- Device
- GORE® VIATORR® TIPS Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S090
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2022-02-22
- Decision code
- OK30
- Date received
- 2022-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of cytotoxicity and infrared spectroscopy inspections for incoming components.