BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cap, Cooling (Infants)

    PMA: P040025 · Supplement: S008 · Decision Dec 24, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cap, Cooling (Infants)
    Trade Name
    OLYMPIC COOL-CAP SYSTEM
    PMA Number
    P040025
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MXM
    Generic Name
    Cap, cooling (infants)
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 24, 2008
    Date Received
    October 27, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR HARDWARE AND SOFTWARE DESIGN CHANGES TO THE OLYMPIC COOL-CAP SYSTEM RELATED TO A CPU (PROCESSOR) THAT HAS GONE END-OF-LIFE.

    Classifications

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

    Product Code Device Name
    MXM Cap, Cooling (Infants)