BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P980003 · Supplement: S005 · Decision Jun 28, 2002
    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
    P980003
    Supplement Number
    S005
    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
    June 28, 2002
    Date Received
    April 9, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) USE OF A COMPATIBLE RADIOFREQUENCY (RF) GENERATOR FOR DELIVERY OF RF ENERGY THROUGH THE TIP OF THE CHILLI COOLED ABLATION CATHETER AND THE ADDITION OF ACCESSORIES TO CONNECT THE CATHETER TO THE RF GENERATOR; 2) A TEMPERATURE SENSOR CONVERTER (MODEL 2067 THERMOCOUPLE TO THERMISTOR TRANSLATOR (TTT) MODULE) FOR THE THERMOCOUPLE OUTPUT OF THE CHILLI COOLED ABLATION CATHETER TO THE THERMISTOR INPUT OF THE COMPATIBLE RF GENERATOR; AND 3) A SEPARATE, COMPATIBLE PUMP (MODEL 8005 PUMP SYSTEM) FOR DELIVERY OF FLUID FLOW THROUGH THE TIP OF THE CHILLI/COOLED ABLATION CATHETER AND A NEW TUBING KIT ACCESSORY (MODEL 2104 STERILE DISPOSABLE TUBE SET) WHICH CONNECTS THE CATHETER TO THE PUMP.

    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