PMA P200035S022

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S022
Product code: QQK
Decision date: 2025-06-10
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: replacement of the stepper motor to the Haydon 4300 Series stepper motor within the OrganOx metra Retained Unit (D0003) due to obsolescence of the prior stepper motor

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S022
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-06-10
Decision code: APPR
Date received: 2025-03-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: replacement of the stepper motor to the Haydon 4300 Series stepper motor within the OrganOx metra Retained Unit (D0003) due to obsolescence of the prior stepper motor