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

    PMA: P960043 · Supplement: S119 · Decision Dec 16, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Prostar™ XL Percutaneous Vascular Surgical System, Perclose ProGlide™ Suture-Mediated Closure System, Perclose™ ProStyle
    PMA Number
    P960043
    Supplement Number
    S119
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 16, 2022
    Date Received
    November 16, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.