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Device | Ventana PD-L1 (SP142) Assay |
Generic Name | immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 east innovation park dr. tucson, AZ 85755 |
PMA Number | P160002 |
Supplement Number | S012 |
Date Received | 01/21/2020 |
Decision Date | 05/18/2020 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Clinical Trials | NCT02409342
|
Supplement Type | normal 180 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the VENTANA PD-L1 (SP142) Assay as a companion diagnostic for identifying patients with non-small cell lung carcinoma (NSCLC) with PD-L1 expression in TC >= 50% or IC >= 10% for treatment with TECENTRIQ based upon the IMpower110 clinical study. |
Labeling | Labeling
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