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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePARADIGM REAL-TIME REVEL SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150019
Date Received06/10/2015
Decision Date12/07/2015
Product Codes MDS OYC 
Docket Number 15M-4728
Notice Date 12/22/2015
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01464346
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PARADIGM REAL-TIME REVEL SYSTEM. THIS DEVICE IS INDICATED FOR:PARADIGM REAL-TIME REVEL INSULIN PUMP. THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523/MMT-723) ARE INDICATED FOR THE CONTINUOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. THE PARADIGM REAL-TIME REVEL SYSTEM CONSISTS OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS, THE ENLITE GLUCOSE SENSOR (MMT-7008), AND THE MINILINK TRANSMITTER (MMT-7703). USE OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS WITH THE OPTIONAL SENSOR AND TRANSMITTER COMPONENTS IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN ADULTS (AGES 18 AND OLDER). ENLITE SENSOR: THE ENLITE SENSOR (MMT-7008) IS INTENDED FOR USE WITH THE PARADIGM REAL-TIME REVEL INSULIN PUMP SYSTEMS (MMT-523/MMT-723) TO CONTINUOUSLY MONITOR GLUCOSE LEVELS IN PERSONS WITH DIABETES.GLUCOSE VALUES PROVIDED BY THE PARADIGM REAL-TIME REVEL SYSTEM ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON THE SENSOR GLUCOSE READINGS PROVIDED BY THE PARADIGM REAL-TIME REVEL SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S016 S017 S018 S020 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 
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