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Food and Drug Administration

Neurological Devices Panel
of the Medical Devices Advisory Committee

January 26, 2007

FDA Presentation

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 space on the screen or on the printed page.

FDA Executive Summary (pdf)

FDA Introduction to Conditions of Approval (CoA) Study Reports, Susan N. Gardener, Ph.D. (pdf)

FDA SSE for Confluent Surgical's DuraSeal (pdf)

Confluent Surgical's DuraSeal CoA Study Report, Eric P. Anker, J.D. (pdf)

FDA DuraSeal CoA Study Report, Khan W. Li, M.D. (pdf)

FDA SEE for Cyberonics VNS (pdf)

Cyberonics VNS CoA Study Report, Danica Marinac-Dabic, M.D., Ph.D. (pdf)

Sponsor Presentation: Neuronetics, Inc.

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)

Comparison of Neuronetics and Reference ECT Dataset Study Populations (pdf)

Description of MADRS and HAMD Depression Rating Scales (pdf)

Expert Statistical Opinion Letter, Philip W. Lavori, Ph.D. (pdf)

Indications for Use (510(k) Submission, Section 4) (pdf)

Device Description (510(k) Submission, Section 11) (pdf)

Substantial Equivalence (510(k) Submission, Section 12) (pdf)

Clinical Performance Data (510(k) Submission, Section 20) (pdf)

Effects of Exposure to TMS Magnetic Fields (510(k) Submission, Appendix 13) (pdf)

Final Study Report (510(k) Submission, Appendix 19) (pdf)

Final Study Report (510(k) Submission, Appendix 20) (pdf)

Interim Study Report (510(k) Submission, Appendix 21) (pdf)

Bibliography (510(k) Submission, Appendix 24) (pdf)

NeuroStar User Manual (Revision 005a, 18 December 2006) (pdf)

510(k) K061053 Table of Contents (pdf)

Page last updated January 25, 2007 kkhorizonal rule
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