PMA P200035S019

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S019
Product code: QQK
Decision date: 2025-06-02
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: Approval for a change to the air vent filter and removal of the air transport warning from the lableing.

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S019
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-06-02
Decision code: APPR
Date received: 2024-11-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the air vent filter and removal of the air transport warning from the lableing.