Packaging, labeling, and final release activities of the one-press serter conducted at medtronic, inc. To be moved to contract manufacturer facility. The one-press serter is a component of the 530g system, the 630g system, the 670g system, and the guardian connect system.
Device | Guardian Connect System |
Classification Name | Sensor, Glucose, Invasive |
Generic Name | Sensor, Glucose, Invasive |
Applicant | MEDTRONIC MINIMED |
Date Received | 2019-10-11 |
Decision Date | 2019-11-04 |
PMA | P160007 |
Supplement | S027 |
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 |
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