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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 NameMEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS097
Date Received04/22/2011
Decision Date05/20/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Inclusion of an alternate supplier for the case assembly used in the manufacture of the paradigm real-time and paradigm real-time revel insulin pumps.
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