BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990025 · Supplement: S030 · Decision Mar 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    EZ STEER NAV ELECTROPHYSIOLOGY CATHETER
    PMA Number
    P990025
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 30, 2012
    Date Received
    March 2, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION 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