PMA P200035

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S003
Product code: QQK
Decision date: 2026-07-08
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval to transfer the fabrication of components of the OrganOx metra Retained Unit from Camden Boss Limited to Ortumex Systems Limited

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S040
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-07-08
Decision code: OK30
Date received: 2026-06-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to transfer the fabrication of components of the OrganOx metra Retained Unit from Camden Boss Limited to Ortumex Systems Limited