BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040022 · Decision Nov 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIOLINK VASCULAR CLOSURE SYSTEM
    PMA Number
    P040022
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 3, 2004
    Date Received
    April 26, 2004
    Expedited Review
    N
    Docket Number
    04M-0496

    Advisory Committee Statement

    APPROVAL FOR THE EVS VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR PERCUTANEOUS FEMORAL ARTERY APPROXIMATION. THE EVS VASCULAR CLOSURE SYSTEM IS ALSO INDICATED TO REDUCE TIME TO HEMOSTASIS AT FEMORAL PUNCTURE SITES AND TO REDUCE TIME TO AMBULATION FOR PATIENTS UNDERGOING DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 6-8 FRENCH 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