Food and Drug Administration

Neurological Devices Panel of the

Medical Devices Advisory Committee

June 17, 2005

Briefing Information

Olympic Medical Corp., Olympic Cool-Cap®, PMA P040025

Executive Summary (PDF)

Panel Recommendation Options for Premarket Approval Applications (HTM) (PDF) (Word)

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.

Summary of Safety and Effectiveness Data (PDF)

Reference List (PDF)