BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S008 · Decision Jul 15, 2004
    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
    S008
    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
    July 15, 2004
    Date Received
    May 19, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO ANGIOJET XMI CATHETER WHICH INCLUDED: 1) ADDITION OF A PROXIMAL MARKER BAND; 2) CHANGES TO THE PROXIMAL SHAFT; AND 3) CHANGES TO THE STRAIN RELIEF.

    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