BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020025 · Supplement: S036 · Decision Aug 7, 2013
    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
    INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER
    PMA Number
    P020025
    Supplement Number
    S036
    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 7, 2013
    Date Received
    November 2, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR BLAZER PRIME XP CATHETER DESIGN MODIFICATIONS, MATERIAL PACKAGING, LABELING CHANGES, AND ADDITION OF ACCESSORIES: INTELLATIP MIFI CABLE, FILTER MODULE, AND REFERENCE CABLE FOR THE INTELLATIP MIFI FAMILY OF CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTELLATIP MIFI XP ABLATION CATHETER AND IS INDICATED FOR USE WITH THE BSC MAESTRO 3000 CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE BSC HIGH POWER 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