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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
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS068
Date Received02/11/2010
Decision Date04/05/2010
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 modification to the paradigm real-time insulin pump to add an insulation pad to the pump motor flex cable and is indicated for continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition to delivery of insulin, the paradigm insulin pump is designed to receive and display real-time glucose values received via a compatible transmitting device.
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