BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S208 · Decision Nov 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS
    PMA Number
    P860019
    Supplement Number
    S208
    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
    November 7, 2008
    Date Received
    April 24, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE APEX MONORAIL AND OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS. THE DEVICE, AS MODIFIED, IS INDICATED FOR: 1) (BALLOON MODELS 1.5 ¿ 5.0 MM) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; AND 2) (BALLOON MODELS 2.0 ¿ 5.0 MM) 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