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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 PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS125
Date Received10/31/2012
Decision Date01/29/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the drive support cap, case bottom bore and additional glue for the paradigm real-time insulin pumps (mmt-722, mmt-722k) and paradigm real-time revel insulin pump (mmt-723, mmt-723k), as components of the paradigm real-time and paradigm real-time revel system.
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