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

    PMA: P170029 · Supplement: S001 · Decision Mar 23, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Trade Name
    Calcivis Imaging System
    PMA Number
    P170029
    Supplement Number
    S001
    Product Code
    QJX
    Generic Name
    Caries detection product with drug or biologic
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 23, 2023
    Date Received
    March 21, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Replace the drug substance manufacturing wash step buffer component of Triton X-100 with Ecosurf SA-9 at the 3P Biopharmaceuticals facility located in Navarra, Spain.