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

    PMA: P960043 · Supplement: S028 · Decision Dec 12, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES
    PMA Number
    P960043
    Supplement Number
    S028
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 12, 2000
    Date Received
    November 13, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REDUCING THE SHEATH TO GUIDE TENSILE STRENGTH ACCEPTANCE CRITERIA TO A MINIMUM OF 5 LBF. FROM 7 LBF.