PMA
P250036: PGDx elio tissue complete CDx
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Personal Genome Diagnostics, Inc.
Key facts
| PMA number | P250036 |
|---|---|
| Trade name | PGDx elio tissue complete CDx |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Personal Genome Diagnostics, Inc. |
| Product code | PQP |
| Approval date | Jul 30, 2026 |
At a glance
- None Supplements
- Jul 30, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: