BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Monitor, Intracranial Pressure, Implanted

    PMA: P820012 · Supplement: S006 · Decision Jul 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Monitor, Intracranial Pressure, Implanted
    Trade Name
    COSMAN ICP TELE-SENSOR(R)
    PMA Number
    P820012
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LII
    Generic Name
    Monitor, intracranial pressure, implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 29, 1999
    Date Received
    August 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).

    Classifications

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

    Product Code Device Name
    LII Monitor, Intracranial Pressure, Implanted