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. |
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Device | PARADIGM REAL-TIME REVEL SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Date Received | 06/10/2015 |
Decision Date | 12/07/2015 |
Product Codes |
MDS OYC |
Docket Number | 15M-4728 |
Notice Date | 12/22/2015 |
Advisory Committee |
Clinical Chemistry |
Clinical Trials | NCT01464346
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Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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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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