BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S019 · Decision May 17, 2013
    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 IMPLANTABLE HEARING SYSTEM
    PMA Number
    P090018
    Supplement Number
    S019
    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
    May 17, 2013
    Date Received
    April 19, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) REVISIONS TO THE INSTRUCTIONS FOR USE FOR THE IMPLANTING SURGEON; 2) A MANUAL TO INFORM AUDIOLOGISTS ON THE PROGRAMMING OF THE ESTEEM SYSTEM; AND 3) FOR MAKING MANUALS, WHICH ARE MADE REDUNDANT BY THE FORMER LABELING CHANGES, OBSOLETE.

    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