PMA P200035S028

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S028
Product code: QQK
Decision date: 2025-08-28
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: adding caution and safety updates within the Instructions for Use (IFU) to enhance the safety of the OrganOx metra System.

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S028
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-08-28
Decision code: APPR
Date received: 2025-08-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: adding caution and safety updates within the Instructions for Use (IFU) to enhance the safety of the OrganOx metra System.