Approval for manufacturing changes related to bioburden testing for the enlite sensor and guardian sensor (3). The enlite sensor is component of the minimed 530g system, the minimed 630g system, the paradigm real-time revel system, and the ipro2 cgm system. The guardian sensor (3) is component of the minimed 670g system, the guardian connect system, and the minimed 630g system with smartguard
| Device | iPro2 CGM System with Enlite Sensor |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2020-11-03 |
| Decision Date | 2020-12-01 |
| PMA | P150029 |
| Supplement | S035 |
| 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