BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060019 · Supplement: S005 · Decision Jun 12, 2009
    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
    THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR
    PMA Number
    P060019
    Supplement Number
    S005
    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
    June 12, 2009
    Date Received
    July 14, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE COOL POINT PUMP AND TUBING SET TO PROVIDE IRRIGATION OF THE THERAPY COOL PATH ABLATION CATHETER AS WELL AS MODIFICATION TO THE IBI 1500T9 RF ABLATION GENERATOR TO FUNCTION WITH THE COOL POINT PUMP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IBI-1500T9-CP RF ABLATION GENERATOR.

    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