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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P990036 · Decision Nov 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    CORDIS CHECKMATE(TM) SYSTEM
    PMA Number
    P990036
    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    Approved (Withdrawn)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 3, 2000
    Date Received
    July 1, 1999
    Expedited Review
    Y
    Docket Number
    00M-1650

    Advisory Committee Statement

    APPROVAL FOR THE CORDIS CHECKMATE(TM) SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF THERAPEUTIC DOSES OF GAMMA RADIATION FOR THE PURPOSE OF REDUCING IN-STENT RESTENOSIS. THE SYSTEM IS FOR USE IN 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