PMA
P160006: VENTANA PD-L1 (SP142) Assay
FDA PMA · Immunohistochemistry assay, antibody, programmed death-ligand 1 · Ventana Medical Systems, Inc.
Key facts
| PMA number | P160006 |
|---|---|
| Trade name | VENTANA PD-L1 (SP142) Assay |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | PLS |
| Approval date | Oct 18, 2016 |
| Docket number | 16M-3431 |
| Notice date | Nov 15, 2016 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- None Supplements
- Oct 18, 2016 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- No Withdrawn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: