BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P930029 · Supplement: S004 · Decision Sep 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    ATAKR(TM) RFCA SYSTEM
    PMA Number
    P930029
    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
    September 30, 1996
    Date Received
    August 30, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDTION OF A GRAPH SHOWING THE RELATIONSHIP OF INITIAL ATAKR POWER OUTPUT TO TEMPERATURE SET POINT DURING THE RAMP UP PERIOD IN TEMPERATURE CONTROL MODE AND THE ADDTION OF A WARNING STATEMENT REARDING PROPER CONNECTION TECHNIQURES WHEN UTILIZING THE ATAKR SYSTEM WITH OTHER CATHETER LABORATORY EQUIPMENT

    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