PMA P200035S035

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S035
Product code: QQK
Decision date: 2026-03-30
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for updated labeling (instructions for use, patient brochure, quick reference guide, training videos, and marketing materials (corporate brochure, surgeon brochure, and corporate overview)

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S035
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-03-30
Decision code: APPR
Date received: 2025-12-31
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for updated labeling (instructions for use, patient brochure, quick reference guide, training videos, and marketing materials (corporate brochure, surgeon brochure, and corporate overview)