BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P080013 · Decision Sep 4, 2009
    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
    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
    September 4, 2009
    Date Received
    April 25, 2008
    Expedited Review
    N
    Docket Number
    09M-0485

    Advisory Committee Statement

    APPROVAL FOR THE DURASEAL XACT SEALANT SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING SPINAL 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