BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990025 · Supplement: S031 · Decision Mar 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
    PMA Number
    P990025
    Supplement Number
    S031
    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 7, 2013
    Date Received
    April 16, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.

    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