PMA P160046S010

Device: VENTANA PD-L1 (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160046
Supplement: S010
Product code: PLS
Decision date: 2021-10-15
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval for the VENTANA PD-L1 (SP263) Assay as a CDx for identifying patients with NSCLC tumors with PD-L1 status of >= 1% TC who may benefit from treatment with TECENTRIQ.

Current openFDA PMA Record#

Device: VENTANA PD-L1 (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160046
Supplement: S010
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2021-10-15
Decision code: APPR
Date received: 2021-06-14
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 CDx for identifying patients with NSCLC tumors with PD-L1 status of >= 1% TC who may benefit from treatment with TECENTRIQ.