BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    PMA: P020025 · Supplement: S004 · Decision Jun 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    EPT-1000 XP CARDIAC ABLATION SYSTEM
    PMA Number
    P020025
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 9, 2004
    Date Received
    December 18, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN DESIGN OF THE EPT-1000 XP CARDIAC ABLATION CONTROLLER. THE CHANGE IN DESIGN INCORPORATES THE ORIGINALLY APPROVED EPT-1000 XP CONTROLLER WITH TRACK WHILE ABLATE (TWA) TECHNOLOGY TO VISUALIZE CATHETER NAVIGATION DURING RF ENERGY DELIVERY USING THE REAL TIME POSITION MANAGEMENT (RPM) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRACK WHILE ABLATE (TWA) EPT-1000 XP CARDIAC ABLATION SYSTEM. THE TWA EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter