BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P980003 · Supplement: S013 · Decision Oct 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    CHILLI II COOLED ABLATION CATHETER
    PMA Number
    P980003
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 14, 2004
    Date Received
    August 30, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES MADE TO THE INTERNAL DISTAL TIP CONFIGURATION AND THE CATHETER SHAFT AS WELL AS CHANGES IN THE MANUFACTURING PROCESS TO BOND THE STEERING MECHANISM TO THE BRAIDED SHAFT FOR THE CHILLI II CARDIAC ABLATION CATHETER.

    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