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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 Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS010
Date Received11/29/2002
Decision Date01/07/2004
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 12M-0965
Notice Date 09/12/2012
Advisory Committee Clinical Chemistry
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the guardian telemetered glucose monitoring system (tgms). The device is indicated for continuous or periodic monitoring of interstitial glucose values in persons with diabetes mellitus. Glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts but glucose values will not be displayed. Up to 21 days of stored data can be downloaded to a personal computer to identify patterns and optimize diabetes management.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling