BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Supplement: S005 · Decision Aug 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM
    PMA Number
    P000052
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MOU
    Generic Name
    Intravascular radiation delivery system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 2002
    Date Received
    February 21, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR HARDWARE AND SOFTWARE CHANGES FOR THE GALILEO SOURCE DELIVERY UNIT, I.E., AN ALTERNATE PRIMARY CIRCUIT BOARD (AMPRO BOARD), LCD DISPLAY AND ASSOCIATED SOFTWARE. THESE CHANGES ARE APPLICABLE TO THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM, WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, THE 27 MM 32P SOURCE WIRE AND THE 27 MM GALILEO CENTERING CATHETER.

    Classifications

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

    Product Code Device Name
    MOU Intravascular Radiation Delivery System