PMA P200035S004

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S004
Product code: QQK
Decision date: 2024-08-22
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: response to the additional information in the Not Approvable letter sent from FDA on January 18, 2024 for the cleaning validation of the MLA using quantitative test methods.

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S004
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2024-08-22
Decision code: APPR
Date received: 2022-06-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: response to the additional information in the Not Approvable letter sent from FDA on January 18, 2024 for the cleaning validation of the MLA using quantitative test methods.