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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 NamePARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS135
Date Received07/24/2013
Decision Date08/23/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of labeling changes to the user guide and to the two package inserts (errata sheets) for the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, and mmt-722k), and for the paradigm real-time revel insulin pumps (models mmt-523, mmt-523k, mmt-723, and 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 systems.
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