Approval of intricon corporation (intricon red fox), 1260 red fox road, saint paul, mn as an alternative finished product manufacturing facility and intricon corporation grey fox (intricon grey fox), 1275 grey fox road arden hills, mn as an alternate final packaging process facility for the guardian link (3) and guardian connect transmitter. The transmitters are components of the minimed 630g system with smartguard, guardian connect system, and minimed 670g system. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment
| Device | Guardian Connect System |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2020-08-04 |
| Decision Date | 2020-09-02 |
| PMA | P160007 |
| Supplement | S037 |
| 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 Street northridge, CA 91325-1219 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160007 | | Original Filing |
| S046 |
2022-11-04 |
30-day Notice |
| S045 | | |
| S044 |
2022-04-01 |
30-day Notice |
| S043 | | |
| S042 |
2021-11-17 |
Special (immediate Track) |
| S041 |
2021-09-20 |
30-day Notice |
| S040 |
2021-01-27 |
Special (immediate Track) |
| S039 |
2020-11-03 |
30-day Notice |
| S038 | | |
| S037 |
2020-08-04 |
30-day Notice |
| S036 |
2020-05-26 |
30-day Notice |
| S035 | | |
| S034 |
2020-01-08 |
30-day Notice |
| S033 |
2019-11-29 |
30-day Notice |
| S032 | | |
| S031 |
2019-11-27 |
30-day Notice |
| S030 |
2019-11-27 |
30-day Notice |
| S029 | | |
| S028 |
2019-10-17 |
30-day Notice |
| S027 |
2019-10-11 |
30-day Notice |
| S026 | | |
| S025 |
2019-08-21 |
30-day Notice |
| S024 |
2019-07-15 |
30-day Notice |
| S023 |
2019-06-19 |
30-day Notice |
| S022 |
2019-05-21 |
30-day Notice |
| S021 |
2019-05-17 |
30-day Notice |
| S020 | | |
| S019 | | |
| S018 | | |
| S017 |
2019-04-03 |
30-day Notice |
| S016 |
2019-02-25 |
30-day Notice |
| S015 |
2019-02-11 |
30-day Notice |
| S014 | | |
| S013 |
2019-02-01 |
30-day Notice |
| S012 | | |
| S011 |
2018-11-02 |
30-day Notice |
| S010 |
2018-10-15 |
30-day Notice |
| S009 |
2018-07-09 |
30-day Notice |
| S008 |
2018-07-02 |
30-day Notice |
| S007 |
2018-06-19 |
30-day Notice |
| S006 |
2018-06-07 |
Special (immediate Track) |
| S005 |
2018-05-31 |
30-day Notice |
| S004 |
2018-05-18 |
Real-time Process |
| S003 |
2018-05-11 |
30-day Notice |
| S002 |
2018-03-29 |
30-day Notice |
| S001 |
2018-03-26 |
30-day Notice |
NIH GUDID Devices