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

    PMA: P140033 · Supplement: S055 · Decision Feb 28, 2020
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI
    PMA Number
    P140033
    Supplement Number
    S055
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 28, 2020
    Date Received
    February 13, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.