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Medical Devices Dispute Resolution Panel

April 19, 2007

Briefing Information

FDA/ODE Briefing Documents (Panel Pack)

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.

Table of Contents (pdf)

Tab 1 - Executive Summary (pdf)

Tab 2 -Background Info (pdf)

Tab 3 - History of Cardima Revelation System (pdf)

Tab 4 - ODE Panel Pack Review Memos (pdf)

Tab 5 - (A-C) - Circulatory Systems Advisory Panel Meeting (May 29, 2003) for P020039:

• Transcript (htm)
• Summary Minutes (htm) (pdf)

Tab 5 - (D-F) - Circulatory Systems Advisory Panel Meeting (May 29, 2003) for P020039 :

• Linear Ablation REVELATION® Tx Microcatheter RF Ablation System (Final), Cardima, Inc. (htm) (ppt)
• Cardima, Inc.'s Revelation? Tx Microcatheter with NavAblator™ RF Ablation System (Final), FDA (htm) ppt)

Tab 6A - References (pdf)

Tab 7 - (A-C) - Appendices (pdf)

Tab 7 (D-E) Appendices continued:

• Circulatory System Devices Advisory Panel Meeting, April 4, 2000 (pdf)
• Circulatory System Devices Advisory Panel Meeting, July 21-22, 1998 (pdf)
• Quotes from 1998 panel discussion of trial design for ablation catheters for AF (pdf)

Sponsors: Cardima Briefing Documents (Panel Pack)

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.

Table of Contents (pdf)

Appendix D – Copyrighted Material

Executive Summary (pdf)

Expert Consultant Opinion Memorandum (pdf)

Clinical Study Summary (pdf)

Rebuttal of FDA Issues (pdf)

Appendix A: Study Protocol (pdf)

Appendix B: Instructions for Use (pdf)

Appendix C: Isthmus Ablation and the NAVABLATOR Ò (pdf)

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