# Personal Genome Diagnostics, Inc.: PMA approval for PGDx elio tissue complete CDx

**Score:** 55/100

| Field | Value |
|---|---|
| Sponsor | Personal Genome Diagnostics, Inc. |
| Product | PGDx elio tissue complete CDx |
| Generic / ingredient | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Approval | PMA original approval (new class III device) |
| Application | P250036 |
| Decided | 2026-07-30 |
| Panel / class | Medical Genetics |
| Sponsor location | Blatimore, MD |

## Why this score
- A new product launch.

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=P250036). 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.