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

    PMA: P950020 · Supplement: S044 · Decision Jun 30, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    FLEXTOME CUTTING BALLOON DILATATION DEVICE
    PMA Number
    P950020
    Supplement Number
    S044
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 30, 2011
    Date Received
    June 1, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.