PMA supplement
P220006 S005: VENTANA FOLR1 (FOLR-2.1) RxDx Assay
FDA PMA supplement · Real-Time Process · Ventana Medical Systems, Inc.
Key facts
| Original PMA | P220006 |
|---|---|
| Supplement number | S005 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VENTANA FOLR1 (FOLR-2.1) RxDx Assay |
| Generic name | Immunohistochemistry Assay, Antibody, FOLR1 |
| Applicant | Ventana Medical Systems, Inc. |
| Product code | QUL |
| Received date | Oct 30, 2023 |
| Decision date | Jan 26, 2024 |
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: