PMA P200035S029
- Device
- OrganOx metra® System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S029
- Product code
- QQK
- Decision date
- 2025-09-08
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Approval order statement
- change in Dosimetry System
Current openFDA PMA Record#
- Device
- OrganOx metra® System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S029
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2025-09-08
- Decision code
- OK30
- Date received
- 2025-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in Dosimetry System