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

    PMA: P950020 · Supplement: S052 · Decision Sep 6, 2012
    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
    S052
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 6, 2012
    Date Received
    August 13, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.