BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990037 · Supplement: S003 · Decision Mar 22, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 22, 2001
    Date Received
    February 7, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INSTRUCTINOS FOR USE MANUAL TO INCLUDE THE OUTCOME DATA (REGISTRY RESULTS) REGARDING PATIENTS TREATED WITH PLATELET GP IIB/IIIA INHIBITORS.