Food and Drug Administration

Circulatory Systems Device Panel

May 29, 2003

Briefing Information

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.

Cardima REVELATION® Tx Microcatheter Ablation System - 1 Page Summary (HTM) (PDF) (Word)

Cardima REVELATION® Tx Cardiac Ablation System - Labeling (PDF) (Word)

Summary of Safety and Effectiveness, Cardima, Inc. (HTM) (PDF) (Word)

Linear Ablation REVELATION® Tx Microcatheter RF Ablation System (Draft), Cardima, Inc. (HTM) (PPT)

Linear Ablation REVELATION® Tx Microcatheter RF Ablation System (Final), Cardima, Inc. (HTM) (PPT)

Cardima, Inc.’s Revelation? Tx Microcatheter with NavAblator™ RF Ablation System (Draft), FDA (HTM) (PPT)

Cardima, Inc.’s Revelation? Tx Microcatheter with NavAblator™ RF Ablation System (Final), FDA (HTM) (PPT)

Diathermy Interactions with Implanted Leads and Implanted Systems with Leads, Office of Surveillance and Biometrics (HTM) (PPT)