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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.
 
DevicePARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS125
Date Received10/31/2012
Decision Date01/29/2013
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
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE DRIVE SUPPORT CAP, CASE BOTTOM BORE AND ADDITIONAL GLUE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-723, MMT-723K), AS COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEM.
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