BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S031 · Decision Apr 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED EL C40+ COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 18, 2008
    Date Received
    January 23, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATIONS AS FOLLOWS: 1) ADAPTION OF ENCLOSED TESTS AT HEADER INCOMING INSPECTION; 2) CHANGE IN INCOMING INSPECTION PROCEDURE FOR CABLES OF REMOTE BATTERY PACK; 3) INTRODUCTION OF SILICONE MIXING MACHINE; 4)CHANGE IN MANUFACTURING PROCEDURE FOR WELDING OF COIL; 5) ALTERNATIVE EQUIPMENT TO MEASURE STRENGTH OF MAGNETS; 6) CHANGES TO ELECTRODE MOULDS; 7) CHANGE IN SPRINT; AND 8) NEW MOULD SHAPE.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear