BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S091 · Decision May 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S091
    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
    May 28, 2013
    Date Received
    July 13, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE AQUA ACCESSORY FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM. THE AQUA ACCESSORY IS A WATER RESISTANT POUCH THAT IS SEALABLE AT ONE END, AND HOLDS THE EXTERNAL NUCLEUS 5 CP810 SOUND PROCESSOR AND COIL. IT MAY BE USED FOR UP TO AN HOUR TO KEEP THE EXTERNAL COMPONENTS DRY DURING USE IN WATER (E.G., SWIMMING). THE AQUA ACCESSORY IS INTENDED FOR UNILATERAL OR BILATERAL USE BY COCHLEAR IMPLANT RECIPIENTS WHO HAVE THE ABILITY TO NOTIFY A CAREGIVER OR THE ABILITY TO REMOVE THE DEVICE ON THEIR OWN, IF THE DEVICE BECOMES HOT OR IF THERE IS A CHANGE IN SOUND QUALITY.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear