BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S002 · Decision Jul 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S002
    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
    July 22, 1998
    Date Received
    July 20, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47uF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120). As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated. With reference to item 1), this change would lower the total harmonic distoriton resulting in improved audio signal. In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear