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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
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS145
Date Received11/08/2013
Decision Date12/06/2013
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 
In-process storage change to a nitrogen cabinet during manufacturing of the sof-sensor (models: mmt-7002 c, d, e).
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