BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P990036 · Supplement: S001 · Decision Jun 13, 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
    S001
    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
    June 13, 2002
    Date Received
    February 13, 2001
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE EXISTING RADIATION DOSIMETRY PROTOCOL FROM A PROTOCOL THAT IS BASED ON INTRAVASCULAR ULTRASOUND (IVUS) TO A PROTOCOL THAT PRESCRIBES A FIXED DOSE OF 14 GY AT A DISTANCE OF 2 MM FROM THE CENTERLINE OF THE SOURCE AND IS INDICATED FOR THE TREATMENT OF NATIVE CORONARY ARTERIES (2.75 - 4.0 MM IN DIAMETER AND LESIONS UP TO AND INCLUDING 45 MM IN LENGTH) WITH IN-STENT RESTENOSIS FOLLOWING PERCUTANEOUS REVASCULARIZATION USING CURRENT INTERVENTIONAL TECHNIQUES.

    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