BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P240027 · Decision Feb 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    SpineSeal Spine Sealant
    PMA Number
    P240027
    Device Class
    FDA Class 3
    Product Code
    NQR
    Generic Name
    Sealant, dural
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 14, 2025
    Date Received
    August 19, 2024
    Expedited Review
    N
    Docket Number
    25M-0438

    Advisory Committee Statement

    The SpineSeal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural