BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P960016 · Supplement: S009 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    LIVEWIRE TC CARDIAC ABLATION SYSTEM
    PMA Number
    P960016
    Supplement Number
    S009
    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
    March 28, 2003
    Date Received
    February 12, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISED INDICATIONS FOR USE FOR THESE MODELS OF LIVEWIRE TC ABLATION CATHETERS: 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH UNIVERSAL SENSOR (MODELS 402205-402208); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMISTOR (MODELS 402209-402212); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMOCOUPLE (MODELS 402213-402216); 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETHER WITH THERMISTOR (MODELS 402229-402232); AND 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER XLS WITH THERMISTOR (MODELS 402233-402236). THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.

    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