BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S003 · Decision Nov 18, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL
    PMA Number
    P960043
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 18, 1997
    Date Received
    October 2, 1997
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes tot he Precautions and Clinical Procedure sections of the Instructions for Use.