BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P920004 · Supplement: S019 · Decision Apr 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASOSEAL DEVICES
    PMA Number
    P920004
    Supplement Number
    S019
    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
    April 3, 2003
    Date Received
    March 14, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MOVE THE REMAINING CHEMICAL PROCESSING AND TEXTILING OPERATIONS FROM THE MANUFACTURING FACILITY IN VAALS, THE NETHERLANDS TO DATASCOPE'S FACILITY LOCATED IN MAHWAH, NEW JERSEY.

    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