BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110010 · Supplement: S001 · Decision Jun 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
    PMA Number
    P110010
    Supplement Number
    S001
    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
    June 1, 2012
    Date Received
    November 30, 2011
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    12M-0562

    Advisory Committee Statement

    APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.

    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