BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060019 · Supplement: S015 · Decision Jan 11, 2011
    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
    S015
    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
    January 11, 2011
    Date Received
    November 16, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.

    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