Advisory Committees
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2011 Meeting Materials of the Neurological Devices Panel
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March 17, 2011: Meeting Materials FDA Generated
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March 18, 2011: Meeting Materials Non-FDA Generated
Package Insert (PDF - 218KB)Patient Labeling (PDF - 8KB)PUFS Protocol Revision (PDF - 253KB)Annual Report (PDF - 4.3MB)Appendix 6- Published Articles (PDF - 79KB)Executive Summary (PDF - 1.4MB)PMA 1000018 Pipeline Emb Dev Response to Deficiencies (PDF - 13.3MB)PMA Module 3 Amendment 1 - 90-Day Update (PDF - 6.6MB)Post-approval study outline Chestnut Medical (PDF - 214KB)SSED (PDF - 462KB)
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March 18, 2011: Meeting Materials FDA-Generated
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January 27-28, 2011: Meeting Materials FDA Generated
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