PMA supplement
P150013 S001: PD-L1 IHC 22C3 PHARMDX
FDA PMA supplement · Panel Track · Agilent Technologies, Inc.
Key facts
| Original PMA | P150013 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PD-L1 IHC 22C3 PHARMDX |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Agilent Technologies, Inc. |
| Product code | PLS |
| Received date | Dec 31, 2015 |
| Decision date | Oct 24, 2016 |
| Docket number | 16M-3913 |
| Notice date | Nov 28, 2016 |
At a glance
- Yes 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: