PMA
P240037: VENTANA MET (SP44) RxDx Assay
FDA PMA · Immunohistochemistry Assay, Antibody, MET · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Key facts
| PMA number | P240037 |
|---|---|
| Trade name | VENTANA MET (SP44) RxDx Assay |
| Generic name | Immunohistochemistry Assay, Antibody, MET |
| Applicant | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | SER |
| Approval date | May 14, 2025 |
| Establishment registration | 2028492 |
| FEI number | 3003054714 |
At a glance
- 1–9 Supplements
- Jul 11, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: