BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P890027 · Supplement: S025 · Decision Feb 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
    PMA Number
    P890027
    Supplement Number
    S025
    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
    February 13, 1996
    Date Received
    October 4, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR COMPONENT AND PROCESS CHANGES TO THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE COMPONENT CHANGE CONSISTS OF REPLACING THE LOWER VALUE NPO DIELECTRIC TRIM CAPACITOR WITH THE SAME BX DIELECTRIC MATERIAL AS USED FOR THE HIGHER VALUE TRIM CAPACITOR. THE PROCESS CHANGE CONSISTS OF PREHEATING THE CAPACITORS AND PRINTED CIRCUIT BOARD PRIOR TO SOLDERING THE CAPACITORS TO THE PCB

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear