BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990054 · Decision Mar 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    CHILLI COOLED ABLATION SYSTEM
    PMA Number
    P990054
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 17, 2000
    Date Received
    September 20, 1999
    Expedited Review
    N
    Docket Number
    00M-1517

    Advisory Committee Statement

    The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, RF ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. In addition, the Chilli Catheter with Tracking is used with the Arrhythmia Mapping and Tracking System to provide catheter location information.

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter