BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    PMA: P010068 · Supplement: S032 · Decision Jul 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS
    PMA Number
    P010068
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 22, 2013
    Date Received
    March 21, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.

    Classifications

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

    Product Code Device Name
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter