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

    PMA: P950020 · Supplement: S047 · Decision Dec 7, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CORONARY FLEXTOME CUTTING BALLOON
    PMA Number
    P950020
    Supplement Number
    S047
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 7, 2011
    Date Received
    November 4, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE MANUFACTURING PROCESS EQUIPMENT BY IMPLEMENTING AN ALTERNATE BIOSLIDE COATING MACHINE, WITH UPDATED HARDWARE, SOFTWARE, AND PROCESSING CHANGES, AS WELL AS A MINOR REARRANGEMENT OF THE EXISTING PRODUCTION EQUIPMENT TO NEW LOCATIONS WITHIN THE CURRENT MANUFACTURING LINE.