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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.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS114
Date Received03/05/2012
Decision Date04/04/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an alternative supercapacitor due to a supply chain problem. Thesupercapacitor 1037110-003 (nec p/n: fgh0h154zf-h5e) will replace 1037110-002 (necpin: fgh0h154zf-le) for the paradigm real-time insulin pump (models mmt-522, -522k,-722, -722k) and paradigm real-time revel insulin pump (models mmt -523, -523k, -723,-723k). The paradigm real-time pump is a component of the paradigm real-time continuousglucose monitoring system. The paradigm real-time revel pump is a component of theparadigm real-time revel continuous glucose monitoring system.