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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 NumberS011
Date Received08/20/2004
Decision Date07/18/2005
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 05M-0454
Notice Date 11/15/2005
Advisory Committee Clinical Chemistry
Supplement Typepanel track
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the guardian rt. The device is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin in adults (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. It alerts if a glucose level falls below or rises above preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments would be based on measurements obtained using a home glucose monitor and not on guardian values. Guardian rt provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose episodes. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to pc software for analysis of historical glucose values.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling