PMA P200035S032

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S032
Product code: QQK
Decision date: 2026-03-16
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: modification of the battery pack fixture that secures the two rechargeable batteries within the base of the metra® System

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S032
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-03-16
Decision code: APPR
Date received: 2025-12-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: modification of the battery pack fixture that secures the two rechargeable batteries within the base of the metra® System