BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S040 · Decision Oct 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM
    PMA Number
    P980037
    Supplement Number
    S040
    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
    October 16, 2012
    Date Received
    August 15, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE PACKAGING TRAY MATERIAL FOR THE ANGIOJET ULTRA XMI, ULTRA SPIROFLEX, AND ULTRA SPIROFLEX VG THROMBECTOMY SETS FROM PETG TO PETG DENEST, AS WELL AS CHANGING THE MANUFACTURING OF THESE PACKAGING TRAYS FROM PERFECSEAL TO BROOKDALE.

    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