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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.
 
DeviceCOOL CAP SYSTEM
Generic NameCap, cooling (infants)
ApplicantNatus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108
PMA NumberP040025
Supplement NumberS005
Date Received08/24/2007
Decision Date09/21/2007
Withdrawal Date 08/02/2023
Product Code MXM 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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