BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990037 · Supplement: S006 · Decision Jun 14, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VASCULAR SOLUTIONS DUETT SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 14, 2001
    Date Received
    May 21, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN THE PRECAUTIONS AND INSTRUCTIONS.