BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110010 · Supplement: S053 · Decision Nov 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
    PMA Number
    P110010
    Supplement Number
    S053
    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
    November 21, 2013
    Date Received
    April 25, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE PROMUS® ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM-CHROMIUM CORONARY STENT SYSTEM: 1)STENT DESIGN MODIFICATIONS TOINCREASE AXIAL STRENGTH; 2) A SHORTER TIP AND COLORANT CHANGE ON THE STENT DELIVERY SYSTEM; 3) MODIFICATIONS TO THE HYPOTUBE COVERING ON THE STENT DELIVERY SYSTEM; AND 4) LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.

    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