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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOLYMPIC COOL-CAP
Generic NameCap, cooling (infants)
ApplicantNatus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108
PMA NumberP040025
Date Received05/28/2004
Decision Date12/20/2006
Product Code MXM 
Docket Number 06M-0530
Notice Date 12/26/2006
Advisory Committee Neurology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 
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