PMA P200035S018

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S018
Product code: QQK
Decision date: 2025-04-16
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: Approval for an additional manufacturing line at Raumedic for the Disposable Set (D0146) component of the OrganOx metra System.

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S018
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-04-16
Decision code: APPR
Date received: 2024-11-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional manufacturing line at Raumedic for the Disposable Set (D0146) component of the OrganOx metra System.