BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S113 · Decision Apr 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER
    PMA Number
    P860019
    Supplement Number
    S113
    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 9, 1997
    Date Received
    May 2, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW BALLOON DILATATION AND INFUSION CATHETER. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) TRANSPORT(R) CORONARY BALLOON DILATATION-INFUSION CATHETER AND IS INDICATD FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FO RTHE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE TRANSPORT(R) CATHETER IS ALSO INTENDED TO INFUSION FLUIDS SUCH AS HEPARINIZED SALINE, AND THROMBOLYTIC AGENTS SUCH AS UROKINASE, INTOT EH VASCULATURE WHEN THE DILATATION BALLOON IS DEFLATED OR INFLATED TO PRESSURES UP TO 3 ATMOSPHERES.

    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