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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS097
Date Received04/22/2011
Decision Date05/20/2011
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
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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