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.
| Device | IPRO2 CGM SYSTEM WITH ENLITE SENSOR |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2015-08-10 |
| Decision Date | 2016-06-17 |
| Notice Date | 2016-06-24 |
| PMA | P150029 |
| Supplement | S |
| Product Code | MDS |
| Docket Number | 16m-1755 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150029 | | Original Filing |
| S038 |
2022-04-01 |
30-day Notice |
| S037 |
2021-11-17 |
Special (immediate Track) |
| S036 |
2021-01-27 |
Special (immediate Track) |
| S035 |
2020-11-03 |
30-day Notice |
| S034 |
2019-11-29 |
30-day Notice |
| S033 |
2019-10-17 |
30-day Notice |
| S032 | | |
| S031 |
2019-08-21 |
30-day Notice |
| S030 |
2019-07-15 |
30-day Notice |
| S029 |
2019-06-19 |
30-day Notice |
| S028 | | |
| S027 |
2019-02-11 |
30-day Notice |
| S026 |
2019-02-01 |
30-day Notice |
| S025 |
2018-11-07 |
30-day Notice |
| S024 |
2018-11-07 |
30-day Notice |
| S023 |
2018-11-02 |
30-day Notice |
| S022 |
2018-10-15 |
30-day Notice |
| S021 |
2018-07-09 |
30-day Notice |
| S020 |
2018-06-19 |
30-day Notice |
| S019 |
2018-06-07 |
Special (immediate Track) |
| S018 |
2018-03-26 |
30-day Notice |
| S017 |
2018-03-12 |
30-day Notice |
| S016 |
2018-02-09 |
Real-time Process |
| S015 |
2018-02-07 |
30-day Notice |
| S014 |
2017-12-22 |
30-day Notice |
| S013 |
2017-11-24 |
30-day Notice |
| S012 |
2017-10-30 |
30-day Notice |
| S011 |
2017-07-17 |
30-day Notice |
| S010 |
2017-06-22 |
Real-time Process |
| S009 |
2017-05-30 |
30-day Notice |
| S008 |
2017-03-31 |
30-day Notice |
| S007 | | |
| S006 |
2016-12-23 |
Real-time Process |
| S005 |
2016-12-12 |
30-day Notice |
| S004 |
2016-11-28 |
30-day Notice |
| S003 |
2016-11-28 |
30-day Notice |
| S002 |
2016-11-02 |
30-day Notice |
| S001 |
2016-07-21 |
30-day Notice |
NIH GUDID Devices