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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 NameSOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS122
Date Received08/23/2012
Decision Date09/18/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change which will incorporate the addition of process water to a once-diluted batch of platinum plating solution for the sof-sensor glucose sensors (models mmt-7002 and mmt-7003) that are components of the devices.
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