BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P930029 · Supplement: S044 · Decision Sep 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR
    PMA Number
    P930029
    Supplement Number
    S044
    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 10, 2014
    Date Received
    July 1, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO SOLDER AND WIRE REQUIRED TO MEET THE EUROPEAN DIRECTIVE 2011/65/EU ¿ RESTRICTION OF THE USE OF CERTAIN HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT.

    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