BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S020 · Decision Mar 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
    PMA Number
    P980037
    Supplement Number
    S020
    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
    March 28, 2007
    Date Received
    September 29, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SPIROFLEX VG CATHETER THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM: SPIROFLEX VG RAPID EXCHANGE RHEOLYTIC THROMBECTOMY CATHETER AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >= 3 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