BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P990036 · Supplement: S003 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    CORDIS CHECKMATE SYSTEM
    PMA Number
    P990036
    Supplement Number
    S003
    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
    July 25, 2002
    Date Received
    June 10, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE REGARDING THE RECOILING OF THE SOURCE RIBBON ON THE SPOOL OF THE DELIVERY DEVICE AND THE USE OF THE METAL CAPS ON THE ENDS OF THE DELIVERY DEVICE.

    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