BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150013 · Supplement: S032 · Decision Feb 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    PD-L1 IHC 22C3 pharmDx
    PMA Number
    P150013
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    PLS
    Generic Name
    Immunohistochemistry assay, antibody, programmed death-ligand 1
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 11, 2026
    Date Received
    August 8, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    26M-1612

    Advisory Committee Statement

    Approval for the PD-L1 IHC 22C3 pharmDx for expanding the indications to include use as an aid in identifying patients with esophageal or GEJ carcinoma for treatment with KEYTRUDA® (pembrolizumab).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1