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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 Namecap,cooling (infants)
Natus Medical Incorporated
5900 first avenue south
seattle, WA 98108
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S005 S006 S007 S008 S009 S010 S011 S012 S013