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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOLYMPIC COOL CAP
Generic NameCap, cooling (infants)
ApplicantNatus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108
PMA NumberP040025
Supplement NumberS013
Date Received05/28/2013
Decision Date08/29/2013
Withdrawal Date 08/02/2023
Product Code MXM 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.
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