BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P220014 · Decision Jul 6, 2023
    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
    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 6, 2023
    Date Received
    September 2, 2022
    Expedited Review
    N
    Docket Number
    23M-3158

    Advisory Committee Statement

    Approval for the CraniSeal Dural Sealant. The device is indicated for use in patients >= 18 years of age as an adjunct to sutured dural repair during cranial 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