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

    PMA: P920047 · Supplement: S013 · Decision Nov 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
    S013
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 30, 1999
    Date Received
    November 5, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the EPT-1000 that will allow the use of alternate biological indicators with a reduced incubation time.