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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 NumberS162
Date Received10/22/2014
Decision Date11/21/2014
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 
Changes to the fabrication process for the sof-sensor (mmt-7002). The sof-sensor is a component of the continuous glucose monitoring system, paradigm real-time system, paradigm real-time revel system, guardian real time cgm system, minilink real-time system, ipro recorder cgm system, and ipro 2 professional cgm system.
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