BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990025 · Supplement: S009 · Decision Jan 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
    PMA Number
    P990025
    Supplement Number
    S009
    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
    January 26, 2006
    Date Received
    April 27, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. WHEN USED WITH THE CARGO? EP NAVIGATION SYSTEM, THE NAVISTAR RMT CATHETER PROVIDES LOCATION INFORMATION.

    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