BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S008 · Decision Jun 11, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PRIMO PREMOUNTED STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S008
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 11, 1999
    Date Received
    May 10, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the specification of the balloon component for the NIR(TM) Primo(TM) Premounted Stent System. This change applies only to the 9 mm length NIR(TM) Primo(TM) Premounted Stent System with the 3.0 mm, 3.5 mm, and 4.0 mm balloon diameters.