BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P010023 · Supplement: S009 · Decision Jul 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Partially Implanted
    Trade Name
    MAXUM SYSTEM
    PMA Number
    P010023
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MPV
    Generic Name
    Implant, hearing, active, middle ear, partially implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 15, 2011
    Date Received
    April 27, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF A MANUFACTURING PROCESS AND SUPPLIER CHANGE TO THE MAGNET CANISTER ASSEMBLY.

    Classifications

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

    Product Code Device Name
    MPV Implant, Hearing, Active, Middle Ear, Partially Implanted