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. |
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Device | OLYMPIC COOL-CAP SYSTEM |
Generic Name | Cap, cooling (infants) |
Applicant | Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108 |
PMA Number | P040025 |
Supplement Number | S007 |
Date Received | 07/16/2008 |
Decision Date | 04/22/2009 |
Withdrawal Date
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08/02/2023 |
Product Code |
MXM |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
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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