PMA
P250046: OncoMate® MSI Dx Analysis System
FDA PMA · Nucleic Acid Based Assay, Microsatellite Instability · Promega Corporation
Key facts
| PMA number | P250046 |
|---|---|
| Trade name | OncoMate® MSI Dx Analysis System |
| Generic name | Nucleic Acid Based Assay, Microsatellite Instability |
| Applicant | Promega Corporation |
| Product code | SFL |
| Approval date | Sep 15, 2026 |
At a glance
- None Supplements
- Sep 15, 2026 Latest supplement decision
- No Withdrawn
- No 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: