BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060019 · Supplement: S013 · Decision Dec 3, 2010
    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
    THERAPY COOL PATH ABLATION CATHETER
    PMA Number
    P060019
    Supplement Number
    S013
    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
    December 3, 2010
    Date Received
    August 30, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CHANGE THE MATERIAL OF THE EXTENSION TUBE TO INCREASE THE TORQUE RESISTANCE OF THE EXTENSION TUBE DURING HANDLE MANIPULATION. THE MATERIAL OF THE EXTENSION TUBE WILL BE CHANGED FROM A NON-BRAIDED PELLETHANE TO A PEBAX BRAIDED TUBE (72D). ADDITIONALLY, THE LENGTH OF THE EXTENSION TUBE AND THE INTERNAL FLUID LUMEN TUBE WILL BE DECREASED FROM 11 CM TO 4 CM.

    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