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

    PMA: P980001 · Supplement: S030 · Decision Apr 10, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S030
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 10, 2001
    Date Received
    March 12, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    EMODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE GEL LUMP SIZE TO THE SOX(TM) COMPONENT FROM 0.005" TO <= 0.010".