BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P980018 · Supplement: S018 · Decision Nov 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    HERCEPTEST
    PMA Number
    P980018
    Supplement Number
    S018
    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
    November 26, 2013
    Date Received
    November 21, 2013
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST. WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS.

    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