Approval for addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the enlite and guardian sensor (3) continuous glucose monitoring sensors. The enlite sensor is a component of the minimed 530g system, the minimed 630g system, the paradigm real-time revel system, and the ipro2 with enlite sensor system. The guardian sensor (3) is a component of the minimed 630g system, the guardian connect system, and the minimed 670g system
| Device | iPro2 CGM System with Enlite Sensor |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2019-08-21 |
| Decision Date | 2019-08-26 |
| PMA | P150029 |
| Supplement | S031 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 |
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