Food and Drug Administration

Neurological Devices Panel of the

Medical Devices Advisory Committee

February 23, 2004

Briefing Information

Cover Letter (HTM) (PDF) (Word)

FDA Device Review (HTM) (PDF) (Word)

Clinical Review, Dr. Michael Schlosser, MD, FDA (HTM) (PDF) (Word)

Statistical Review, Judy Chen, MS, FDA (HTM) (PDF) (Word)

510(k) Premarket Notification - Concentric MERCI® Retriever, Concentric Medical, Inc. (PDF)

MERCI Clinical Investigation (Mechanical Embolus Removal in Cerebral Ischemia) - Summary of Clinical Results to Date (PDF)

MERCI Clinical Investigation (Mechanical Embolus Removal in Cerebral Ischemia) - Revised Summary of Clinical Results n = 114 Patients (PDF)

Updated Clinical Data, FDA (HTM) (PDF) (Word)

Panel Statistician Dr. Jonas Ellenberg, PhD (HTM) (PDF) (Word)

Response to Statistics Review, Concentric Medical, Inc. (PDF)