BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P060008 · Supplement: S047 · Decision May 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
    PMA Number
    P060008
    Supplement Number
    S047
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 17, 2010
    Date Received
    March 19, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent