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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecap,cooling (infants)
Generic Namecooling cap (infants)
PMA NumberP040025
Date Received05/28/2004
Decision Date12/20/2006
Product Code
MXM[ Registered Establishments with MXM ]
Docket Number 06M-0530
Notice Date 12/26/2006
Advisory Committee Neurology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the olympic cool-cap. The olympic cool-cap is indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (hie). Cool-cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with hie.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S005 S006 S007 S008 S009 S010 S011 S012 S013