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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOLYMPIC COOL-CAP SYSTEM
Classification Namecap,cooling (infants)
Generic Namecooling cap (infants)
ApplicantNATUS MEDICAL, INC.
PMA NumberP040025
Supplement NumberS007
Date Received07/16/2008
Decision Date04/22/2009
Product Code
MXM[ Registered Establishments with MXM ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes associated with software upgrade from cool-cap 1. 0 to cool-cap 1. 1, as well as associated labeling changes.
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