BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Scaffold, Infrapopliteal, Absorbable

    PMA: P230036 · Supplement: S013 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Scaffold, Infrapopliteal, Absorbable
    Trade Name
    Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
    PMA Number
    P230036
    Supplement Number
    S013
    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
    August 8, 2025
    Date Received
    July 10, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of revisions to the Esprit BTK-PAS – New Enrollment Study protocol (ABT-CIP-10519 Ver. C)

    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