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

    PMA: P900056 · Supplement: S209 · Decision Jul 27, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Rotablator Rotational Atherectomy System
    PMA Number
    P900056
    Supplement Number
    S209
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 27, 2023
    Date Received
    June 27, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the PLC software/control system for a sterilization chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility