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

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S084 · Decision Sep 25, 2013
    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, PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM
    PMA Number
    P960043
    Supplement Number
    S084
    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
    September 25, 2013
    Date Received
    August 26, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REMOVING A REDUNDANT INSPECTION FOR BLEEDBACK LUMEN PATENCY FROM THE MANUFACTURING PROCESS.

    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