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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.
 
DeviceSLEEP SENTRY
Classification Namemonitor, skin resistance/skin temperature, for insulin reactions
Generic Namemonitor, skin resistance/skin temperature, for insulin reactions
Applicant
DIABETES SENTRY PRODUCTS, LLC
501 samuels ave.
unit #110
fort worth, TX 76102
PMA NumberP810044
Supplement NumberS004
Date Received04/30/2002
Decision Date06/12/2003
Product Code
LMY[ Registered Establishments with LMY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES. THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA.
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