BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P870036 · Supplement: S039 · Decision Aug 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS
    PMA Number
    P870036
    Supplement Number
    S039
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 30, 1996
    Date Received
    June 24, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW BALLOON SIZES TO BE ADDED TO THE FALCON 20 CORONARY BALLOON DILATATION CATHETER LINE AND THE ADDTION OF THE FALCON 30 AND FALCON 40 COROANRY BALLOON DILATATION CATHETER LINES. ALSO, SPECIFICATION AND QUALITY CONTROL INSPECTION CHANGES WERE REQUESTED

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous