BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P980001 · Supplement: S013 · Decision Nov 4, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM
    PMA Number
    P980001
    Supplement Number
    S013
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 4, 1999
    Date Received
    October 6, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR(TM) PRIMO(TM) Premounted Stent Delivery System.