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

    PMA: P980001 · Supplement: S038 · Decision Sep 26, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR STENT DELIVERY SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S038
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 26, 2001
    Date Received
    August 30, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATIVE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR NIR(R) AND NIROYAL(R) STENT DELIVERY SYSTEMS. THE ALTERNATIVE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.