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

    PMA: P950020 · Supplement: S053 · Decision Sep 7, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    FLEXTOME CUTTING BALLOON
    PMA Number
    P950020
    Supplement Number
    S053
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 7, 2012
    Date Received
    August 16, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    AN ALTERNATE SUPPLIER FOR THE BALLOON PROTECTOR CAP COMPONENT; AND MINOR DIMENSIONAL CHANGES FOR THE BALLOON PROTECTOR CAP COMPONENT.