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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 SYSTEM
Generic NameCap, cooling (infants)
ApplicantNatus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108
PMA NumberP040025
Supplement NumberS006
Date Received10/24/2007
Decision Date02/05/2008
Withdrawal Date 08/02/2023
Product Code MXM 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE TO THE PUMP MOTOR DRIVE AND CHANGES TO THE CONTROL MODULE AND TEMPERATURE SENSOR MODULE TO RELIABLY MEET ELECTRICAL FAST TRANSIENT (EFT) TESTING.
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