BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P790017 · Supplement: S074 · Decision Jan 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    D114S OTW BALLOON DILATATION CATHETER
    PMA Number
    P790017
    Supplement Number
    S074
    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 8, 2001
    Date Received
    September 14, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF SIX (6) CATALOGUE ITEMS TO THE APPROVED D114S OVER-THE-WIRE BALLOON DILATATION CATHETER PRODUCT LINE. THESE SIX ITEMS CONSIST OF A 10 MM BALLOON LENGTH IN EACH OF THE CURRENT BALLOON DIAMETERS OF 1.5 MM, 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, AND 4.0 MM. IN ADDITION, APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO THE 1.5 MM DIAMETER EXTRUDED BALLOON TUBING (0.0135"/0.0205" ID/OD FROM THE CURRENT 0.014"/0.022" ID/OD. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

    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