Food and Drug Administration
June 17, 2005
Olympic Medical Corp., Olympic Cool-Cap®, PMA P040025
Executive Summary (PDF)
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)