BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P920047 · Supplement: S012 · Decision Mar 30, 1999
    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
    S012
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 30, 1999
    Date Received
    March 23, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new technique for bonding the proximal to distal segment of the catheters.