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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 NameMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS109
Date Received02/08/2012
Decision Date03/09/2012
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 
Implementation of a new cleaning system called isopropyl alcohol recirculating cleaning or iparc. The iparc system is used to clean the sensor base and needle assembly components of the sof-sensor glucose sensor (mmt-7002, mmt-7003). The sof-sensor is a component of the paradigm real-time system, paradigm real-time revel system, guardian real-time system, cgms ipro system and ipro2 professional continuous glucose monitoring (cgm) system.
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