BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P040034 · Supplement: S033 · Decision Jan 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    DuraSeal Dural Sealant System
    PMA Number
    P040034
    Supplement Number
    S033
    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
    January 25, 2023
    Date Received
    March 12, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for changes to the polycarbonate resin for the spray tip and Y-connector components and to extend the shelf life from 18 months to 24 months for the DuraSeal Dural Sealant System and the DuraSeal Exact Spine Sealant System

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural