BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Scaffold, Infrapopliteal, Absorbable

    PMA: P230036 · Supplement: S016 · Decision Oct 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Scaffold, Infrapopliteal, Absorbable
    Trade Name
    Esprit BTK RX System; Esprit BTK OTW System
    PMA Number
    P230036
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    NXW
    Generic Name
    Scaffold, infrapopliteal, absorbable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 22, 2025
    Date Received
    September 29, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change to the sponge used during the catheter lubricious coating application process

    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