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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 NameSEN-SERTER, MODEL: MMT-7500
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS111
Date Received02/15/2012
Decision Date03/14/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes for the sen-server component of the device.
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