BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P990052 · Supplement: S004 · Decision Jul 24, 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
    S004
    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 24, 2001
    Date Received
    June 20, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION TO THE MOUNTING OF THE ELECTRONIC MODULE ASSEMBLY, THE MICROPHONE AND THE PROGRAMMING SOCKET; CHANGE IN THE PHYSICAL SHAPE OF THE MAGNET FROM A NOTCHED-SHAPE TO A FULL ROUND SHAPE; CHANGE IN THE MATERIAL OF THE TIP COVER OF THE AUDIO PROCESSOR (AP) TO ACRYLONITRILE-BUTADIENE-STYRENE COPOLYMER (ABS) AND ADDITION OF THREE DIFFERENT COLORS (LIGHT BROWN, BROWN AND GRAY) TO BETTER MATCH THE HAIR COLORS OF THE FINAL USERS; AND PICTORIAL AND TEXT CHANGES TO REFLECT THE NEW SHAPE AND COLOR OF THE AP IN REFERENCE MANUAL FOR AUDIOLOGISTS AND PATIENT USER MANUAL.

    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