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

    PMA: P980035 · Supplement: S782 · Decision Jun 5, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SWCOMBO / Application Software, SW030 / Application Software
    PMA Number
    P980035
    Supplement Number
    S782
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 5, 2024
    Date Received
    May 7, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    transfer of receiving and inspection activities from Medtronic Rice Creek manufacturing facility (Fridley, Minnesota) to Medtronic’s Memphis Manufacturing facility (Memphis, Tennessee)