BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P040014 · Supplement: S004 · Decision Jan 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    THERAPY ABLATION CATHETERS
    PMA Number
    P040014
    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
    January 10, 2007
    Date Received
    September 5, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR 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