Food and Drug Administration

Circulatory Systems Devices Panel

April 10, 2003

Briefing Information


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.

Draft Summary of Safety and Effectiveness Data (SSED) (PDF) (Word)

Zenith, Endovascular Graft: Suggested Instructions for Use (PDF)