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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
Predetermined Change Control Plan AuthorizedNo
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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