BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P150005 · Supplement: S005 · Decision Jul 7, 2016
    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
    INTELLANAV OPEN-IRRIGATED ABLATION CATHETER
    PMA Number
    P150005
    Supplement Number
    S005
    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
    July 7, 2016
    Date Received
    April 11, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design changes to incorporate a magnetic sensor into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaNav Open-Irrigated Ablation Catheter and is indicated for: The IntellaNav™ Open-Irrigated Catheter, when used with a Maestro 4000® Radiofrequency (RF) Controller and MetriQ™ Irrigation Pump, is indicated for:1) cardiac electrophysiological mapping; 2) delivering diagnostic pacing stimuli; and 3) RF ablation of sustained or recurrent type 1 atrial flutter in patients age 18 years or older.

    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