BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P890043 · Supplement: S035 · Decision Apr 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
    PMA Number
    P890043
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 6, 2001
    Date Received
    March 6, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM. THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM IS INDICATED FOR USE IN CORONARY ARTERY DISEASE ACCESSIBLE TO DCA (DIRECTIONAL CORONARY ATHERECTOMY), GENERALLY IN THE PROXIMAL OR MID-PORTION OF CORONARY VESSELS. IT CAN BE USED ALONE OR IN CONJUNCTION WITH OTHER CORONARY INTERVENTIONAL DEVICES. DCA IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER BY MECHANICALLY SHAVING AND REMOVING ATHEROSCLEROTIC MATERIAL FROM THE DISEASED VESSEL.

    Classifications

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

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy