BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S005 · Decision Oct 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
    PMA Number
    P000025
    Supplement Number
    S005
    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 29, 2002
    Date Received
    October 15, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AS A MODIFICATION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AND IS INDICATED FOR USE WHERE THERE IS PLANNED ACCESS TO THE INNER EAR DURING SURGERY.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear