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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.
Classification Namecap,cooling (infants)
Generic Namecooling cap (infants)
PMA NumberP040025
Supplement NumberS012
Date Received01/26/2012
Decision Date03/27/2012
Product Code
MXM[ Registered Establishments with MXM ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a redesigned printed circuit board (the syscam pcb, previously pn 401339 and now pn 002819), for the device.