Advisory Committees
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Briefing Materials (May 14, 2009: Neurological Devices Panel Meeting)
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.
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 redacted portions will
appear as white spaces on the screen or on the printed page.
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Related Briefing Documents
Executive Summary (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 2.6MB)Voting Options (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 59KB)FDA Questions (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 160KB)Sponsors Executive Summary (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 3.1MB)Proposed Summary of Safety and Effectiveness (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 1.1MB)Multi-Center Randomized Controlled Study (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 3.3MB)Amendment 1 to DuraSeal Xact Sealant System (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 611KB)Amendment 2 to DuraSeal Spine Sealant System (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 3MB)Labeling for 2ml and 5ml DuraSeal Xact Sealant System (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 129KB)Package Insert (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 404KB)Directions for Use (May 14, 2009: Neurological Devices Panel Meeting) (PDF - 153KB)
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