BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S087 · Decision Mar 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PROCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM
    PMA Number
    P960043
    Supplement Number
    S087
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 20, 2014
    Date Received
    February 19, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE SUPPLIER FOR THE EPTFE FIBER USED IN ONE OF THE COMPONENTS AND MINOR ASSOCIATED MANUFACTURING CHANGES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGB Device, Hemostasis, Vascular