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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 NameCOOL CAP SYSTEM
Classification Namecap,cooling (infants)
Generic Namecooling cap (infants)
ApplicantOLYMPIC MEDICAL CORP.
PMA NumberP040025
Supplement NumberS005
Date Received08/24/2007
Decision Date09/21/2007
Product Code
MXM
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Replacing a mechanical test gauge with an electronic gauge and the release of an acceptance test procedure for the periodic verification of all test fixtures.
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