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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.
 
DeviceIPRO2 CGM SYSTEM WITH ENLITE SENSOR
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP150029
Date Received08/10/2015
Decision Date06/17/2016
Product Codes MDS OZO 
Docket Number 16m-1755
Notice Date 06/24/2016
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the iPro2 System. This device is indicated for:The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.The iPro2 system:1) Is intended for prescription use only;2) Does not allow data to be made available directly to patients in real time;3) Provides data that will be available for review by physicians after the recording interval (up to 144 hours);4) Is intended for occasional rather than everyday use; and5) Is to be used only as a supplement, and not a replacement for, standard invasive measurement.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 
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