BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P070015 · Supplement: S036 · Decision May 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
    PMA Number
    P070015
    Supplement Number
    S036
    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
    May 23, 2011
    Date Received
    April 29, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATES TO YOUR LABELING TO INCLUDE 1-YEAR RESULTS FROM THE SPIRIT IV TRIAL, A POOLED SPIRIT II-III-IV ANALYSIS, GENDER-SPECIFIC ANALYSES, AND UPDATED RESULTS FROM THE SPIRIT FIRST, II, AND III TRIALS.

    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