BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S035 · Decision Dec 20, 2002
    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 STS PLUS PLATFORM
    PMA Number
    P930038
    Supplement Number
    S035
    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
    December 20, 2002
    Date Received
    November 20, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INSERTION SHEATH (ADDITION OF PUNCTURE HOLES), GUIDEWIRE (INCREASE GUIDEWIRE SIZE FOR THE 6FR. DEVICE), PUNCTURE LOCATOR (MOVE LOCATOR HOLES, LABEL LOCATION (MOVE TO OUTSIDE OF PACKAGE) AND THE INSTRUCTIONS FOR USE (REVISE LABELING TO INCLUDE NEW INSTRUCTIONS RELATED TO THESE DESIGN CHANGES).

    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