Changes to the test method and acceptance criteria for the glucose layer membrane solution release testing that is performed for use of the solution in enlite sensor fabrication. The enlite sensor is a component of the minimed 530g system, minimed 630g system, paradigm real-time revel system, and ipro2 continuous glucose monitoring system.
| Device | IPRO2 CGM SYSTEM WITH ENLITE SENSOR |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2017-07-17 |
| Decision Date | 2017-08-16 |
| PMA | P150029 |
| Supplement | S011 |
| 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