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. |
|
Device | COOL CAP SYSTEM |
Generic Name | Cap, cooling (infants) |
Applicant | Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108 |
PMA Number | P040025 |
Supplement Number | S005 |
Date Received | 08/24/2007 |
Decision Date | 09/21/2007 |
Withdrawal Date
|
08/02/2023 |
Product Code |
MXM |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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. |
|
|