BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000052 · Supplement: S023 · Decision Mar 16, 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 SYSTEM
    PMA Number
    P000052
    Supplement Number
    S023
    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 16, 2004
    Date Received
    January 9, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, VERSION 63-033/N. THE SOFTWARE WAS REVISED TO INCREASE THE DISTAL STOP FORCE OF THE ACTIVE SOURCE WIRE.

    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