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

    PMA: P010031 · Supplement: S098 · Decision May 14, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ATTAIN SD
    PMA Number
    P010031
    Supplement Number
    S098
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 14, 2008
    Date Received
    April 14, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.