BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P990052 · Supplement: S006 · Decision Oct 26, 2001
    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 SYSTEM
    PMA Number
    P990052
    Supplement Number
    S006
    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
    October 26, 2001
    Date Received
    September 24, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO THE AUDIO PROCESSOR MODEL 404. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT(R) SOUNDBRIDGE(TM) AUDIO PROCESSOR MODEL 404SR. THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.

    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