Food and Drug Administration

Circulatory Drugs Advisory Committee

January 13, 2005

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.

Instructions for Use for the GORE TAG Thoracic Endoprosthesis, (PDF)

Patient Information Booklet, W. L. Gore & Assoc., Inc. (PDF)

Clinical Summary, W. L. Gore & Assoc., Inc. (PDF)

Draft Summary of Safety and Effectiveness, W. L. Gore & Assoc., Inc. (PDF)

Review Summary, FDA (PDF)