BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Dural

    PMA: P040034 · Supplement: S007 · Decision Nov 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
    S007
    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
    November 2, 2006
    Date Received
    August 24, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF DATA COLLECTED AT ELEVATED TEMPERATURES (I.E., ACCELERATED AGING DATA) TO DETERMINE FUTURE SHELF LIFE CLAIMS FOR THE DEVICE, APPLYING A CORRELATION FACTOR OF Q10=3. THE USE OF THE CORRELATION FACTOR WITH TEST DATA OBTAINED AT 35 DEGREES C COLLECTED OUT TO 26 WEEKS ACCURATELY PREDICTS PRODUCT EXPIRATION DATING TO 18 MONTHS, REAL-TIME.

    Classifications

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

    Product Code Device Name
    NQR Sealant, Dural