BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110013 · Supplement: S049 · Decision Apr 8, 2015
    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
    S049
    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
    April 8, 2015
    Date Received
    December 18, 2014
    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 FOR UPDATES TO THE INSTRUCTIONS FOR USE FOR BOTH THE RAPID EXCHANGE AND OVER-THE-WIRE DELIVERY SYSTEMS WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE VARIOUS STUDIES OF THE GLOBAL RESOLUTE CLINICAL TRIAL PROGRAM.

    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