BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P130014 · Supplement: S021 · Decision Nov 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    Adherus AutoSpray Dural Sealant
    PMA Number
    P130014
    Supplement Number
    S021
    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
    November 6, 2025
    Date Received
    March 11, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for use of an automated vial filling system and to perform a packaging step outside of a glove box.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural