BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P150022 · Decision Feb 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    CLOSER VASCULAR SEALING SYSTEM
    PMA Number
    P150022
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2016
    Date Received
    June 25, 2015
    Expedited Review
    N
    Docket Number
    16M-0805

    Advisory Committee Statement

    Approval for the Closer Vascular Sealing System (VSS). This device is indicated for the percutaneous closure of femoral artery access sites while reducing times to hemostasis and ambulation as compared to Performance Goals in patients who have undergone diagnostic or interventional endovascular procedures utilizing 5, 6 and 7 Fr procedural sheaths.

    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