BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S020 · Decision Apr 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    BTE(BEHIND-THE-EAR)T-MIC
    PMA Number
    P960058
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 2002
    Date Received
    April 12, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE BTE T-MIC, AND IN-THE-EAR MICROPHONE ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR, AND APPROVAL OF THE HIFOCUS I SURGICAL INSTRUCTION VIDEO, WHICH WILL BE DISTRIBUTED AS PART OF THE SURGEON'S KIT.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear