BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020025 · Decision Aug 25, 2003
    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
    EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
    PMA Number
    P020025
    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
    August 25, 2003
    Date Received
    June 24, 2002
    Expedited Review
    N
    Docket Number
    03M-0427

    Advisory Committee Statement

    APPROVAL FOR THE EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM. THE BLAZER II XP CARDIAC ABLATION CATHETER IS INDICATED FOR USE WITH THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE 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