BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S047 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
    PMA Number
    P990081
    Supplement Number
    S047
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 30, 2022
    Date Received
    May 27, 2022
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-2439

    Advisory Committee Statement

    Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody for expanding the indications to include testing for breast cancer patients who are eligible for treatment with ENHERTU®.

    Classifications

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

    Product Code Device Name
    MVC System, Test, Her-2/Neu, Ihc