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

    PMA: P980001 · Supplement: S025 · Decision Oct 12, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S025
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 12, 2000
    Date Received
    September 18, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE 30-DAY NOTICE PROPOSED A CHANGE IN AN IN-PROCESS INSPECTION STEP TO REMOVE THE STENT IMPRINT AS A REJECTION CRITERION FOR THE ELASTOMERIC RETAINING SLEEVE COMPONENT ACCEPTANCE