BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110013 · Supplement: S059 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
    PMA Number
    P110013
    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
    July 22, 2016
    Date Received
    January 27, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to update the labeling for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) for both the Rapid Exchange (RX) and Over-The-Wire (OTW) delivery systems to include the most current clinical follow-up data for the Global RESOLUTE Clinical Trial Program and the Resolute Integrity US (RI-US) Primary Enrollment Group (PEG) Post-Approval Study.

    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