BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990025 · Supplement: S011 · Decision Mar 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    QWIKSTAR NAVIGATION/ABLATION CATHETER
    PMA Number
    P990025
    Supplement Number
    S011
    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
    March 28, 2006
    Date Received
    January 18, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MINOR LABELING REVISION FOR THE 4 MM QWIKSTAR DIAGNOSTIC/ABLATION CATHETER TO INCLUDE THE NOGA XP NAVIGATION SYSTEM AS AN OPTIONAL MAPPING SYSTEM FOR THE QWIKSTAR CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIO-FREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. WHEN USED IN THE CARTO XP EP OR NOGA XP NAVIGATION SYSTEMS, THE QWIKSTAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION AND APPROXIMATE CATHETER TIP CURVATURE.

    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