BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P980003 · Supplement: S012 · Decision Feb 9, 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
    S012
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 9, 2004
    Date Received
    January 14, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    FOUR MANUFACTURING CHANGES: 1) CHANGE TO COOLING LUMEN EXTRUSION; 2) CHANGE TO FLUX CLEANING PROCESS; 3) CHANGE FROM 1X TO 2X KEVLAR WRAP; AND 4) CHANGE FROM MOLDED TO MACHINED DISTAL RING ELECTRODE GROOVES.

    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