BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P080013 · Supplement: S028 · Decision Oct 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    DuraSeal Exact Spine Sealant System
    PMA Number
    P080013
    Supplement Number
    S028
    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
    October 30, 2024
    Date Received
    June 21, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in the vented vial adapter component for the diluent syringe to connect to the polyethylene glycol (PEG) powder vial of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System, which also resulted in changes to the PEG powder vial closure system, usability, labeling, and packaging.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural