BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S046 · Decision Oct 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIO-SEAL VASCULAR CLOSURE DEVICE
    PMA Number
    P930038
    Supplement Number
    S046
    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
    October 5, 2006
    Date Received
    October 12, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REMOVE THE CURRENT PRECAUTION PERTAINING TO PATIENTS WITH PERIPHERAL VASCULAR DISEASE (PVD) FROM THE SPECIAL PATIENT POPULATIONS SECTION AND ADD A PRECAUTION TO TE PROCEDURE SECTION, IDENTIFYING PUBLISHED CLINICAL EXPERIENCE OF PATIENTS WITH PVD.

    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