BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P960016 · Supplement: S004 · Decision Jun 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER
    PMA Number
    P960016
    Supplement Number
    S004
    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 14, 2001
    Date Received
    March 30, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1 (ONE) YEAR SHELF-LIFE, THE INCORPORATION OF ADDITIONAL ELECTRODES FOR STIMULATION AND MAPPING (10 ELECTRODES TOTAL), AND OTHER MINOR DEVICE MODIFICATIONS. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC COMPASS CATHETER AND IS INDICATED FOR USE FOR CARDIAC ELECTROPHYSIOLOGICAL. MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL BLOCK RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETION AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR TO AN ATRIAL ARRHYTHMIA.

    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