BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P030025 · Supplement: S059 · Decision Mar 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
    PMA Number
    P030025
    Supplement Number
    S059
    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
    March 20, 2009
    Date Received
    September 29, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE SIZE OF THE SIBS PIECES AND THE PROCESS FOR MIXING AND FILTERING THE SPRAY COATING SOLUTION USED TO MANUFACTURE THE DEVICE.

    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