BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P220014 · Supplement: S005 · Decision Jul 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Sealant, Dural
    Trade Name
    CraniSeal Dural Sealant
    PMA Number
    P220014
    Supplement Number
    S005
    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
    July 2, 2025
    Date Received
    April 2, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to replace the current Tyvek/PET (Mylar) pouch outer packaging to a Tyvek/Nylon pouch.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural