BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110016 · Supplement: S004 · Decision Sep 7, 2012
    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 DUO ABLATION CATHETER
    PMA Number
    P110016
    Supplement Number
    S004
    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
    September 7, 2012
    Date Received
    July 10, 2012
    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 BOND BETWEEN THAT CATHETER SHAFT AND THE EXTENSION TUBING. SPECIFICALLY, YOU PROPOSE TO CHANGE THE ADHESIVE FROM LOCTITE TO URETHANE AND TO MODIFY THE CONTACT HOLE FROM A CIRCULAR TO AN OCTAGONAL SHAPE.

    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