PMA supplement
P160002 S009: VENTANA PD-L1(SP142) Assay.
FDA PMA supplement · Panel Track · Ventana Medical Systems, Inc.
Key facts
| Original PMA | P160002 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VENTANA PD-L1(SP142) Assay. |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Ventana Medical Systems, Inc. |
| Product code | PLS |
| Received date | Sep 14, 2018 |
| Decision date | Mar 8, 2019 |
| Docket number | 19M-1310 |
| Notice date | Mar 20, 2019 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: