BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P070015 · Decision Jul 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
    PMA Number
    P070015
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 2, 2008
    Date Received
    June 1, 2007
    Expedited Review
    N
    Docket Number
    08M-0535

    Advisory Committee Statement

    APPROVAL FOR THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, WHICH WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 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