Food and Drug Administration

Circulatory Systems Devices Panel

April 10, 2003

Slides

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.

Cook Endovascular Graft for AAA, Clinical Data From Two Prospective Studies Two Independent Registries, Paul Chandeysson, FDA (HTM) (PPT)

Cook Zenith® AAA Endovascular Graft and the H&L-B One-Shot? Introduction System P020018 (HTM) (PPT)

Statistical Issues at Time of PMA Review, Gary L. Kamer, FDA (HTM) (PPT)