BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S025 · Decision Aug 3, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICE
    PMA Number
    P960043
    Supplement Number
    S025
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 3, 2000
    Date Received
    July 3, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING MODIFICATION TO THE FOOT COMPONENT OF THE CLOSER(TM) SMC DEVICE.