BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P050007 · Supplement: S006 · Decision Jul 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
    PMA Number
    P050007
    Supplement Number
    S006
    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
    July 30, 2007
    Date Received
    May 7, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.

    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