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

    PMA: P010031 · Supplement: S093 · Decision Apr 3, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO
    PMA Number
    P010031
    Supplement Number
    S093
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 3, 2008
    Date Received
    March 4, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF THE INSPECTION CRITERIA FOR THE OPEN ANODE BOTTOM (OAB) AND OPEN CATHODE BOTTOM (OCB) SEPARATOR USED IN THE BATTERY OF MULTIPLE IMPLANTABLE DEVICES.