Adding an alternate injection molding machine and mold to produce the needle hub body component. The changes will apply to the enlite sensor and guardian sensor (3) which are part of the minimed 530g, minimed 630g, paradigm real-time revel, ipro2 cgm, and medtronic 670g systems.
| Device | iPro2 System |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2018-03-12 |
| Decision Date | 2018-04-10 |
| PMA | P150029 |
| Supplement | S017 |
| 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