PMA supplement
P150027 S004: PD-L1 IHC NIVOLUMAB PHARMDX
FDA PMA supplement · Real-Time Process · Dako North America, Inc.
Key facts
| Original PMA | P150027 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PD-L1 IHC NIVOLUMAB PHARMDX |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Dako North America, Inc. |
| Product code | PLS |
| Received date | Dec 27, 2016 |
| Decision date | Mar 24, 2017 |
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: