BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P150003 · Supplement: S093 · Decision Jun 12, 2023
    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®), SYNERGY™ SHIELD Everolimus-Eluting Plat
    PMA Number
    P150003
    Supplement Number
    S093
    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 12, 2023
    Date Received
    March 14, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the labeling, device packaging, and addition of the 48 mm device delivery system to allow for alignment of the product matrix to include the 48-mm stent size.

    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