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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
