BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020025 · Supplement: S012 · Decision Oct 18, 2005
    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
    MAESTRO 3000 TM CARDIAC ABLATION SYSTEM
    PMA Number
    P020025
    Supplement Number
    S012
    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
    October 18, 2005
    Date Received
    July 18, 2005
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM. THE BOSTON SCIENTIFIC CORPORATION ABLATION CATHETERS WHICH ARE COMPATIBLE WITH THE MAESTRO CARDIAC ABLATION SYSTEM ARE THE BLAZER II/BLAZER II HTD, BLAZER II XP, BLAZER RPM , BLAZER XP RPM, POLARIS T/POLARIS T HTD, CHILLI II, AND STEEROCATH-T.

    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