# Organox Limited: PMA supplement approved for OrganOx metra® System

**Score:** 60/100

| Field | Value |
|---|---|
| Sponsor | Organox Limited |
| Product | OrganOx metra® System |
| Generic / ingredient | Normothermic machine perfusion system for the preservation of donor livers prior to transplantation |
| Approval | PMA supplement (device change) |
| Application | P200035 S038 |
| Decided | 2026-10-09 |
| Panel / class | Gastroenterology, Urology |
| Sponsor location | Oxford |

## Why this score
- Decided in the last 30 days.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200035S038). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.