PMA P200035S023

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S023
Product code: QQK
Decision date: 2025-04-15
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: that the scope of raw material allocation for bile salts be extended to include all countries listed on the EDQM certificate and not only from the United States of America

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S023
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-04-15
Decision code: OK30
Date received: 2025-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: that the scope of raw material allocation for bile salts be extended to include all countries listed on the EDQM certificate and not only from the United States of America