BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Supplement: S010 · Decision Aug 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
    PMA Number
    P000052
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MOU
    Generic Name
    Intravascular radiation delivery system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 2, 2002
    Date Received
    July 5, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    AMENDING IMPLEMENTATION OF MANUFACTURING CHANGES DESCRIBED IN P000052/S007, APPROVED APRIL 17, 2002 AND ADDING A VERIFICATION STEP TO THE PREVENTIVE MAINTENANCE CHECKLIST FOR THE GALILEO SOURCE DELIVERY UNIT.

    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