BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S150 · Decision Apr 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
    PMA Number
    P860019
    Supplement Number
    S150
    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
    April 8, 1999
    Date Received
    October 5, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the SCIMED NC MAXXUM(TM) PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, -5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2.5-4.0mm in 1/4mm increments and 4.5mm - 5.0mm) in 1/2mm increments. The NC MAXXUM(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion. The NC MAXUUM(TM) PTCA Catheter (balloon models 2.5-4.0mm in diameter) 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