BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P100013 · Decision May 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
    PMA Number
    P100013
    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
    May 19, 2011
    Date Received
    April 1, 2010
    Expedited Review
    N
    Docket Number
    11M-0430

    Advisory Committee Statement

    APPROVAL FOR THE EXOSEAL VASCULAR CLOSURE DEVICE. THIS DEVICE IS INDICATED AS FOLLOWS: THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS INDICATED FOR FEMORAL ARTERY PUNCTURE SITE CLOSURE, REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING A STANDARD 5F, 6F, OR 7F VASCULAR SHEATH INTRODUCER WITH UP TO 12 CM WORKING LENGTH. ADDITIONALLY, THE EXOSEAL VCD IS INDICATED TO REDUCE TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL CATHETERIZATION PROCEDURES, USING A STANDARD 6F VASCULAR SHEATH INTRODUCER UP TO A 12 CM WORKING LENGTH, WHO HAVE RECEIVED PREPROCEDURAL AND/OR INTRAPROCEDURAL GLYCOPROTEIN (GP) IIB/IIIA INHIBITOR THERAPY.

    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