PMA P160046S013

Device: VENTANA PD-L1 (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
Product code: PLS
Decision date: 2023-03-01
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
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.

Current openFDA PMA Record#

Device: VENTANA PD-L1 (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160046
Supplement: S013
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2023-03-01
Decision code: APPR
Date received: 2022-04-21
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.