BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P210027 · Decision Nov 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
    Trade Name
    QDOT MICRO™ System
    PMA Number
    P210027
    Device Class
    FDA Class 3
    Product Code
    OAE
    Generic Name
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 23, 2022
    Date Received
    July 6, 2021
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Biosense Webster QDOT MICRO Catheter and related accessory devices. The device is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of:1) Type I atrial flutter in patients age 18 or older; and2) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The QDOT MICRO Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System.

    Classifications

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

    Product Code Device Name
    OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation