BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Supplement: S021 · Decision Mar 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
    PMA Number
    P000052
    Supplement Number
    S021
    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
    March 4, 2004
    Date Received
    September 30, 2003
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE P-32 SOURCE WIRE MANUFACTURING PROCESS TO INCORPORATE AN AUTOMATED SOURCE WIRE ASSEMBLY STATION (SWAS) AS AN ALTERNATE PROCESS FOR FINAL ASSEMBLY OF P-32 SOURCE WIRES.

    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