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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 Namemonitor, skin resistance/skin temperature, for insulin reactions
Generic Namemonitor, skin resistance/skin temperature, for insulin reactions
501 samuels ave.
unit #110
fort worth, TX 76102
PMA NumberP810044
Supplement NumberS005
Date Received02/28/2005
Decision Date04/08/2005
Product Code
LMY[ Registered Establishments with LMY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change of the device web address, and a change to the name of the device. The device, as modified, will be marketed under the trade name diabetes sentry.