PMA P200035S041

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S041
Product code: QQK
Decision date: 2026-08-07
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for revalidation of the endotoxin (LAL) test method of the Sodium Taurocholate/Bile Salts (C0364) component of the D0146/D0146-US Disposable Set

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S041
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-08-07
Decision code: OK30
Date received: 2026-07-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for revalidation of the endotoxin (LAL) test method of the Sodium Taurocholate/Bile Salts (C0364) component of the D0146/D0146-US Disposable Set