BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P150003 · Supplement: S058 · Decision Aug 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
    PMA Number
    P150003
    Supplement Number
    S058
    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
    August 10, 2020
    Date Received
    December 5, 2019
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    20M-1760

    Advisory Committee Statement

    Approval for the SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems.The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, 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 <= 5.00 mm in diameter in lesions <= 34 mm in length.The SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at 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 <= 5.00 mm in diameter in lesions <= 44 mm in length and for high risk bleeding patients with coronary arteries >= 2.25 mm to <= 5.00 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