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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 NameGUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS121
Date Received08/17/2012
Decision Date09/13/2012
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 
Reinstatement of the ayutthaya, thailand facility as an additional facility for the manufacture of printed circuit board assemblies and stack subassemblies used by medtronic minimed in the production of the paradigm real-time insulin pump (models mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin pump (models mmt-523, mmt-523k, mmt-723, and mmt-723k)) and guardian real-time monitor (css7100, css7 100k). The paradigm real-time insulin pump, paradigm real-time revel insulin pump, and guardian real-time monitor are components of the devices.
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