BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Flow Directed

    PMA: P810046 · Supplement: S214 · Decision Mar 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43

    Basic Information

    Device Name
    Catheter, Flow Directed
    Trade Name
    VOYAGER OTW CORONARY DILATION CATHETER
    PMA Number
    P810046
    Supplement Number
    S214
    Device Class
    FDA Class 2
    Product Code
    DYG
    Generic Name
    CATHETER, FLOW DIRECTED
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 12, 2004
    Date Received
    September 15, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER OTW CORONARY DILATATION CATHETER AND IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, 3) BALLOON DILATATION OF A STENT AFTER IMPLANTATION.

    Classifications

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

    Product Code Device Name
    DYG Catheter, Flow Directed