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Food and Drug Administration

Neurology Devices Panel Meeting

May 14,2009

Briefing Information

FDA

Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA
and FDA does not necessarily agree with the sponsor's statements. FDA has not made a
final determination about the safety or effectiveness of the product described in this
document.

Executive Summary (pdf)
Voting Options (pdf)
FDA Questions (pdf)

Sponsor

Disclaimer
Portions of this document have been determined to be exempt from disclosure under the
Freedom of Information Act (the FOIA) (5 U.S.C. $552). These redactedportions will
appear as white spaces on the screen or on theprintedpage.

Sponsors Executive Summary (pdf)
Proposed Summary of Safety and Effectiveness (pdf)
Multi-Center Randomized Controlled Study (pdf)
Amendment 1 to DuraSeal Xact Sealant System (pdf)
Amendment 2 to DuraSeal Spine Sealant System (pdf)
Labeling for 2ml and 5ml DuraSeal Xact Sealant System (pdf)
Package Insert (pdf)
Directions for Use (pdf)

Page last updated May 12, 2009 kkhorizonal rule
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