BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S030 · Decision Mar 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Totally Implanted
    Trade Name
    ESTEEM
    PMA Number
    P090018
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    OAF
    Generic Name
    Implant, hearing, active, middle ear, totally implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 18, 2016
    Date Received
    September 23, 2015
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.

    Classifications

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

    Product Code Device Name
    OAF Implant, Hearing, Active, Middle Ear, Totally Implanted