BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P950005 · Decision Sep 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
    PMA Number
    P950005
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 30, 1997
    Date Received
    April 3, 1995
    Expedited Review
    N
    Docket Number
    98M-0678

    Advisory Committee Statement

    Approval for the Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter. This device includes the following models: six curve types (A, B, C, D, E, and F); tip electrode (4mm tip large and grooved); connector type [Redel 10-pin connector (temperature sensing version) and Nexus plug (non-temperature-sensing version)]; spacing [standard 2-5-2 spacing (center to center measurement of ring electrode spacing)]. This device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) condution pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia; and, creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter