BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S061 · Decision Apr 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    HARMONY HIRESOLUTION BIONIC EAR SYSTEM
    PMA Number
    P960058
    Supplement Number
    S061
    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 21, 2008
    Date Received
    March 24, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY. DO NOT USE ANY OTHER BATTERY.? TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT. PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES. OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT BATTERY LIFE WHEN USED WITH THE ICONNECT.?

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear