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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.
 
DeviceGUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS010
Date Received11/29/2002
Decision Date01/07/2004
Product Code 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 ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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