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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.
 
DeviceDIABETES SENTRY
Generic NameMonitor, skin resistance/skin temperature, for insulin reactions
ApplicantDiabetes Sentry Products, LLC
501 Samuels Ave.
Unit #100
Fort Worth, TX 76102
PMA NumberP810044
Supplement NumberS005
Date Received02/28/2005
Decision Date04/08/2005
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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