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

    PMA: P980016 · Supplement: S022 · Decision Oct 24, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
    PMA Number
    P980016
    Supplement Number
    S022
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 24, 2001
    Date Received
    September 24, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.