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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 NamePARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS137
Date Received08/27/2013
Decision Date09/24/2013
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 
Addition of an alternate facility warehouse space for the handling of raw materials including subassemblies and components for the paradigm real-time insulin pumps (mmt-522, mmt-522k, mmt-722, mmt-722k) and paradigm real-time revel insulin pumps (mmt-523, mmt-523k, mmt-723, mmt-723k). The paradigm real-time insulin pumps are components of the paradigm real-time system and the paradigm real-time revel insulin pumps are components of the paradigm real-time revel system.
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