Food and Drug Administration

Circulatory System Devices Panel

October 23, 2002



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.

Embol-X Clinical Reviews, Dr. Wolf Sapirstein, MD and Dr. Julie Swain, MD Cardiothoracic Surgery (HTM) (PPT)

Embol-X Aortic Filter, Catherine Wentz, et. al., FDA (HTM) (PPT)

Embol-X Clinical Reviewers, Dr. Julie Swain, MD, FDA (HTM) (PPT)

Embol-X Aortic Filter, Statistical  Comments, Gerry Gray, FDA (HTM) (PPT)