PMA P160002S015

Device: VENTANA PD-L1 (SP142) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160002
Supplement: S015
Product code: PLS
Decision date: 2021-09-28
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approved for removal of the triple negative breast cancer (TNBC) indication from the device intended use statement and labeling.

Current openFDA PMA Record#

Device: VENTANA PD-L1 (SP142) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160002
Supplement: S015
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2021-09-28
Decision code: APPR
Date received: 2021-09-07
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approved for removal of the triple negative breast cancer (TNBC) indication from the device intended use statement and labeling.