PMA P200035S024
- Device
- OrganOx metra System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S024
- Product code
- QQK
- Decision date
- 2025-07-01
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Approval order statement
- approval for an updated cavity design for the Cartridge Tray, OrganOx Part Number C0009
Current openFDA PMA Record#
- Device
- OrganOx metra System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S024
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2025-07-01
- Decision code
- APPR
- Date received
- 2025-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an updated cavity design for the Cartridge Tray, OrganOx Part Number C0009