- Device
- OrganOx metra® System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S014
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2024-03-28
- Decision code
- APPR
- Date received
- 2024-02-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval to change the OrganOx metra Liver Perfusion Circuit (Part Number D0146). The change included the replacement of the tubing for the Bile Duct Cannulation Pack due to a supply shortage of the original cannula