PMA P200035S020
- Device
- OrganOx metra System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S020
- Product code
- QQK
- Decision date
- 2024-12-17
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Approval order statement
- Additional supplier manufacturing location for PendoTECH Pressure Sensors.
Current openFDA PMA Record#
- Device
- OrganOx metra System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S020
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2024-12-17
- Decision code
- OK30
- Date received
- 2024-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier manufacturing location for PendoTECH Pressure Sensors.