BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S167 · Decision Jan 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    (R) QUANTUM MONORAIL(TM) PTCA CATHETER
    PMA Number
    P860019
    Supplement Number
    S167
    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
    January 11, 2001
    Date Received
    November 17, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE BOSTON SCIENTIFIC SCIMED QUANTUM MONORAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (9, 12, 15, 18, AND 20 MM LENGTHS WITH BALLOON DIAMETERS OF 2.5 - 4.0 MM IN 1/4 MM INCREMENTS). THE QUANTUM MONORAIL PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE QUANTUM MONORAIL PTCA CATHETER (2.5 - 4.0 MM BALLOON DIAMETERS) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.

    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