BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P040034 · Supplement: S027 · Decision Mar 21, 2018
    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
    S027
    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
    March 21, 2018
    Date Received
    November 30, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing sites located at Avail/Med S.A. De C.V., C.Industrial Lt.001 Mz 105, No. 206905 Int.a.Col. Cd. Industrial, Tijuana, Baja California, Mexico 22444 for manufacture of the DuraSeal® Dural Sealant System and DuraSeal® Exact Spine Sealant System, and Synergy Health AST, LLC, 9020 Activity Road, Suite D, San Diego, California for sterilization of the devices.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural