PMA P200035S037

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S037
Product code: QQK
Decision date: 2026-07-07
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for changing the packaging material for the sterile barrier of the Syringe Filter Adapter component (C0195) included in the Perfusion Pack of the Disposable Set (D0146/D0146-US)

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S037
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-07-07
Decision code: APPR
Date received: 2026-04-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for changing the packaging material for the sterile barrier of the Syringe Filter Adapter component (C0195) included in the Perfusion Pack of the Disposable Set (D0146/D0146-US)