BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S039 · Decision Jan 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
    PMA Number
    P980037
    Supplement Number
    S039
    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
    January 9, 2013
    Date Received
    November 15, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW DEVICE, THE ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEXTHROMBECTOMY SET WITH A 3 FRENCH DISTAL DIAMETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEX THROMBECTOMY SET AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SVG LESIONS IN VESSELS ¿ 2.0 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.

    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