BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P010023 · Supplement: S011 · Decision May 4, 2015
    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
    PMA Number
    P010023
    Supplement Number
    S011
    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
    May 4, 2015
    Date Received
    May 29, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.

    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