|
Device | PD-L1 IHC 22C3 pharmDX |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Agilent Technologies, Inc. 5301 Stevens Creek Blvd Santa Clara, CA 95051 |
PMA Number | P150013 |
Supplement Number | S020 |
Date Received | 06/29/2020 |
Decision Date | 11/13/2020 |
Product Code |
PLS |
Docket Number | 20M-2201 |
Notice Date | 11/19/2020 |
Advisory Committee |
Pathology |
Clinical Trials | NCT02819518
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the PD-L1 IHC 22C3 pharmDX for expanding the indications to include detection of PD-L1 protein in patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|