PMA P200035S026

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S026
Product code: QQK
Decision date: 2025-08-22
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for modifications to improve non-patient contacting hardware components for the Metra Retained Unit (D003)

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S026
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-08-22
Decision code: APPR
Date received: 2025-06-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for modifications to improve non-patient contacting hardware components for the Metra Retained Unit (D003)