|
Device | VENTANA PD-L1 (SP263) Assay |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P160046 |
Supplement Number | S013 |
Date Received | 04/21/2022 |
Decision Date | 03/01/2023 |
Product Code |
PLS |
Docket Number | 23M-0905 |
Notice Date | 03/16/2023 |
Advisory Committee |
Pathology |
Clinical Trials | NCT03088540
|
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 VENTANA PD-L1 (SP263) Assay as a companion diagnostic for identifying patients with non-small cell lung carcinoma (NSCLC) with PD-L1 expression of >= 50% tumor cells (TC) for treatment with LIBTAYO. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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