PMA P200035S038

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S038
Product code: QQK
Decision date: 2026-10-09
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: changing the supplier of the Blood Reservoir, minor manufacturing process changes for the filter materials, and increasing the wall thickness of the five (5) tubing segments in the blood circulation loop of Disposable Set (D0146/D0146-US)

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S038
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-10-09
Decision code: APPR
Date received: 2026-04-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: changing the supplier of the Blood Reservoir, minor manufacturing process changes for the filter materials, and increasing the wall thickness of the five (5) tubing segments in the blood circulation loop of Disposable Set (D0146/D0146-US)