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 | IPRO2 CGM SYSTEM WITH ENLITE SENSOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150029 |
Date Received | 08/10/2015 |
Decision Date | 06/17/2016 |
Product Codes |
MDS OZO |
Docket Number | 16m-1755 |
Notice Date | 06/24/2016 |
Advisory Committee |
Clinical Chemistry |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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