Organox Limited: PMA supplement approved for OrganOx metra® System
Organox Limited (Oxford): PMA supplement approved for OrganOx metra® System. Dated 27 days ago, it is in the active follow-up window. Score 60/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| 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 |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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60 / 100 Score
- Decided in the last 30 days.
What is the FdaApprovalPulse record for Organox Limited in Oxford?
The FDA approved OrganOx metra® System (P200035 S038) for Organox Limited on 2026-10-09: PMA supplement (device change).
How does Organox Limited compare to other FdaApprovalPulse records?
It is 27 days old, still within a typical 45-day follow-up window.
Organox Limited vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Organox Limited | Oxford | 2026-10-09 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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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.