BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P100010 · Supplement: S015 · Decision Apr 12, 2012
    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
    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
    PMA Number
    P100010
    Supplement Number
    S015
    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
    April 12, 2012
    Date Received
    February 17, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CATHETER CHANGES TO INCREASE THE UNIFORMITY OF THE DISTAL BALLOON SURFACE TEMPERATURE (INCREASED NUMBER OF REFRIGERANT PORTS ON THE INJECTION TUBE COIL, MORE DISTAL POSITION OF THE INJECTION TUBE, INCREASED REFRIGERANT FLOW ON THE 28MM BALLOON), TO ADD NEW VISUAL MARKER ON THE CATHETER SHAFT AND TO IMPLEMENT ADDITIONAL MINOR CHANGES TO THE DESIGN AND LABELING.

    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