BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Scaffold, Infrapopliteal, Absorbable

    PMA: P230036 · Decision Apr 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Scaffold, Infrapopliteal, Absorbable
    Trade Name
    Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
    PMA Number
    P230036
    Device Class
    FDA Class 3
    Product Code
    NXW
    Generic Name
    Scaffold, infrapopliteal, absorbable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 26, 2024
    Date Received
    October 31, 2023
    Expedited Review
    N
    Docket Number
    24M-2122

    Advisory Committee Statement

    The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with Chronic Limb Threatening Ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of >= 2.5 mm and <= 4.00 mm.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NXW Scaffold, Infrapopliteal, Absorbable