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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.
 
DevicePRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS116
Date Received03/26/2012
Decision Date05/24/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF A CHANGE OF THE FIELD EFFECT TRANSISTOR (FET), A COMPONENTOF THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME MONITOR (MODELS CSS7100 AND CSS7100K), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME SYSTEMS.
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