BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S002 · Decision Aug 3, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR ON RANGER PREMOUNTED STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 3, 1999
    Date Received
    September 14, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the postapproval study protocol for the NIR ON(TM) Ranger w/SOX(TM) and NIR ON(TM) Ranger(TM) Premounted Stent Systems.