BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cap, Cooling (Infants)

    PMA: P040025 · Supplement: S007 · Decision Apr 22, 2009
    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
    S007
    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
    April 22, 2009
    Date Received
    July 16, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES ASSOCIATED WITH SOFTWARE UPGRADE FROM COOL-CAP 1.0 TO COOL-CAP 1.1, AS WELL AS ASSOCIATED LABELING CHANGES.

    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)