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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.
 
Trade NameCONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS076
Date Received06/08/2010
Decision Date11/17/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modifications of the coating process from the spin coating process to the slot coating process, and the adhesion promoter (ap) solution.
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