BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Angioplasty, Peripheral, Transluminal

    PMA: P950020 · Supplement: S010 · Decision Jul 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94

    Basic Information

    Device Name
    Catheter, Angioplasty, Peripheral, Transluminal
    Trade Name
    FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
    PMA Number
    P950020
    Supplement Number
    S010
    Device Class
    FDA Class 2
    Product Code
    LIT
    Generic Name
    Catheter, angioplasty, peripheral, transluminal
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2005
    Date Received
    September 13, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN, MANUFACTURING, AND LABELING CHANGES IN THE CUTTING BALLOON, BOTH OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXTOME CUTTING BALLOON AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.

    Classifications

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

    Product Code Device Name
    LIT Catheter, Angioplasty, Peripheral, Transluminal