BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110013 · Decision Feb 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
    PMA Number
    P110013
    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
    February 17, 2012
    Date Received
    April 1, 2011
    Expedited Review
    N
    Docket Number
    12M-0177

    Advisory Committee Statement

    APPROVAL FOR THE RESOLUTE MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETERS IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH 27 <= MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.2 MM.

    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