PMA P200035S030

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S030
Product code: QQK
Decision date: 2025-09-19
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: moving the manufacturing of the Disposable Set (D0146) liver bowl clip component from the current manufacturer/supplier, Rutland Plastics, to Fischer Sohne AG

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S030
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-09-19
Decision code: OK30
Date received: 2025-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: moving the manufacturing of the Disposable Set (D0146) liver bowl clip component from the current manufacturer/supplier, Rutland Plastics, to Fischer Sohne AG