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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; PARADIGM REAL-TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS176
Date Received02/26/2015
Decision Date08/25/2015
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design and manufacturing changes to the dscap and case bottom to include a metric thread interface for the paradigm real-time insulin pumps, paradigm real-time revel insulin pumps (model numbers mmt-522, 522k, 523, 523k, 722, 722k, 723, 723k), and minimed 530g insulin pumps (model numbers mmt-551, 751), which are components of the paradigm real-time and paradigm real-time revel continuous glucose monitoring system, and theminimed 530g system.
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