BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990025 · Supplement: S035 · Decision Jul 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES
    PMA Number
    P990025
    Supplement Number
    S035
    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
    July 22, 2013
    Date Received
    March 21, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.

    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