PMA supplement
P240037 S001: VENTANA MET (SP44) RxDx Assay
FDA PMA supplement · Normal 180 Day Track No User Fee · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Key facts
| Original PMA | P240037 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | VENTANA MET (SP44) RxDx Assay |
| Generic name | Immunohistochemistry Assay, Antibody, MET |
| Applicant | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Product code | SER |
| Received date | Jun 11, 2025 |
| Decision date | Jul 11, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: