BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Decision Nov 2, 2001
    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
    Device Class
    FDA Class 3
    Product Code
    MOU
    Generic Name
    Intravascular radiation delivery system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 2, 2001
    Date Received
    December 18, 2000
    Expedited Review
    N
    Docket Number
    01M-0508

    Advisory Committee Statement

    APPROVAL FOR THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, 27 MM GALILEO CENTERING CATHETER, AND 27 MM 32P SOURCE WIRE. THE DEVICE IS INDICATED 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 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