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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P920004 · Decision Sep 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASOSEAL (TM)
    PMA Number
    P920004
    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    Approved (Withdrawn)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
    September 29, 1995
    Date Received
    February 3, 1992
    Expedited Review
    N
    Docket Number
    95m-0394

    Advisory Committee Statement

    APPROVAL FOR THE VASOSEAL VASCULAR HEMOSTASIS DEVICE (VHD) IN ADDITION TO INDICATION ALREADY MENTIONED ALSO INDICATED FOR USE IN PTCA PATIENTS WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED

    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