BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P150003 · Supplement: S055 · Decision May 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)
    PMA Number
    P150003
    Supplement Number
    S055
    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 28, 2020
    Date Received
    October 28, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 48 mm device lengths for the 2.50 to 4.00 mm devices along with modifications to the delivery catheter design and changes to the packaging design. The device, as modified, will be marketed under the trade name SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >= 2.25 mm to <= 5.0 mm in diameter in lesions <= 44 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