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

    PMA: P920047 · Supplement: S014 · Decision Apr 24, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    EPT-1000 CARDIAC ABLATION SYSTEM
    PMA Number
    P920047
    Supplement Number
    S014
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 24, 2001
    Date Received
    March 26, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE MANUFACTURING OPERATION: A CHANGE IN THE WELDING PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS, A CHANGE IN THE GRIT BLAST MEDIA, AND REMOVAL OF A CHEMICAL TO THE WELD JOINT.