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

    PMA: P950020 · Supplement: S058 · Decision Dec 13, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CORONARY FLEXTOME CUTTING BALLON
    PMA Number
    P950020
    Supplement Number
    S058
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 13, 2012
    Date Received
    November 15, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF ALTERNATE MANUFACTURING EQUIPMENT TO TEST FOR BALLOON LEAKS IN THE DEVICE.