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

    PMA: P990045 · Supplement: S022 · Decision Mar 14, 2018
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ETI-AB-COREK PLUS Assay
    PMA Number
    P990045
    Supplement Number
    S022
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 14, 2018
    Date Received
    February 14, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Add a filtration step and an in-process bioburden control to a raw material process, and to relocate a QC-testing process within the site.