BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S104 · Decision Oct 23, 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
    S104
    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
    October 23, 2013
    Date Received
    January 16, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear