BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P040034 · Supplement: S004 · Decision Aug 2, 2006
    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
    S004
    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
    August 2, 2006
    Date Received
    June 8, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) USE OF NOF CORPORATION AS AN ALTERNATE VENDOR FOR FUNCTIONALIZING RAW PEG-POLYOL MATERIAL TO PEG-SG FOR USE IN THE DURASEAL DURAL SEALANT PRODUCT, AND 2) IMPLEMENTATION OF AN IN-PROCESS PARTICLE SIZE INSPECTION STEP PRIOR TO THE MILLING STEP.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural