BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Supplement: S004 · Decision Sep 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM
    PMA Number
    P000052
    Supplement Number
    S004
    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
    September 19, 2002
    Date Received
    December 11, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM AND IS INDICATED AS FOLLOWS: "THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS <= 47 MM IN A REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM."

    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