Manufacturing changes for the guardian sensor (3): 1) adding a new iso class 8 cleanroom for the manufacturing of enlite sensors and guardian sensors (3); 2) adding a new press, two new molds and a new quality control measurement system at the contract manufacturer; 3) adding an alternate injection molding machine and mold to produce the needle hub body component; 4) adding an alternative mask aligner; 5) adding a new electroplating machine; 6) adding a new sterilization site for the enlite sensor and the guardian sensor (3); 7) introducing an alternative press and mold to manufacture the sensor cap components of the guardian sensor (3) and implementing a new configuration number for parts manufactured. The guardian sensor (3) is a component of the guardian connect system
| Device | Guardian Sensor (3) System |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2018-05-31 |
| Decision Date | 2018-06-26 |
| PMA | P160007 |
| Supplement | S005 |
| Product Code | MDS |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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