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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 INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS133
Date Received02/22/2013
Decision Date01/15/2014
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REDUCTION OF KEYPAD BUTTON (DOME) SIZES, NEW KEYPAD OVERLAY SUPPLIER (BERGQUIST), AND KEYPAD/ OVERLAY/ CASE ASSEMBLY PROCESS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K) THAT ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEMS, RESPECTIVELY.
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