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

    PMA: P900061 · Supplement: S170 · Decision Jun 14, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    End Cap, Epicardial Patch Lead, Upsizing Sleeve
    PMA Number
    P900061
    Supplement Number
    S170
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 14, 2023
    Date Received
    June 7, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of an automated pressure monitoring system.