PMA P160002S012

Device: Ventana PD-L1 (SP142) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160002
Supplement: S012
Product code: PLS
Decision date: 2020-05-18
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
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.

Current openFDA PMA Record#

Device: Ventana PD-L1 (SP142) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160002
Supplement: S012
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2020-05-18
Decision code: APPR
Date received: 2020-01-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.