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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.
 
DeviceMINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS007
Date Received06/05/2001
Decision Date02/20/2002
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW VERSION OF SOFTWARE.
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