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

    PMA: P030054 · Supplement: S391 · Decision Apr 9, 2021
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass
    PMA Number
    P030054
    Supplement Number
    S391
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 9, 2021
    Date Received
    March 12, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adjust sample size for bacterial endotoxin testing.