BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S022 · Decision May 19, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLOSER 6 FR. SUTURE-MEDIATED CLOSURE DEVICE
    PMA Number
    P960043
    Supplement Number
    S022
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 2000
    Date Received
    March 23, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE MECHANISM FOR FOOT DEPLOYMENT AND FOOT PARKING OF THE CLOSER(TM) SMC DEVICE.