BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P990052 · Supplement: S013 · Decision Nov 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Partially Implanted
    Trade Name
    VIBRANT SOUNDBRIDGE
    PMA Number
    P990052
    Supplement Number
    S013
    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
    November 2, 2006
    Date Received
    July 12, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ESTABLISH A SECOND SOURCE SUPPLIER, MORGAN ADVANCED CERAMICS, FOR THE DEMODULATOR HOUSING (IMPLANT ELECTRONICS CASE).

    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