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Food and Drug Administration

Medtronic Briefing INDEX

VOLUME 1

Section 4: Sponsor Executive Summary
Section 5: Product Description
Section 6: Endeavor Clinical Experience – Individual Trial Summaries

1. Introduction
2. ENDEAVOR I
3. ENDEAVOR II
4. ENDEAVOR II CA
5. ENDEAVOR III
6. ENDEAVOR IV
7. ENDEAVOR PK
8. ENDEAVOR Japan
9. ENDEAVOR V

Section 7: Endeavor Proposed Post Approval Study
            Attachment 7A Post-approval Study

Section 8: Endeavor Summary of Safety and Effectiveness Data

Section 9: Labeling
Attachment 9A OTW IFU
Attachment 9B RX IFU
Attachment 9C MX IFU
Attachment 9D Patient Guide

VOLUME 2

Section 10: References
Appendix 1: ENDEAVOR I 48 month report
Appendix 2: ENDEAVOR II 36 month report

VOLUME 3

Appendix 3:
ENDEAVOR II CA 24 month report

Appendicies 4-8
Appendix 4: ENDEAVOR III 24 month report
Appendix 5: ENDEAVOR IV 9 month report
Appendix 6: ENDEAVOR PK 9 month report
Appendix 7: ENDEAVOR Japan 9 month report
Appendix 8: ENDEAVOR V 30 day report   


Page last updated October 5, 2007 kkhorizonal rule
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