Automate the software loading process performed during manufacture of the t:slim g4 insulin pump at the tandem diabetes care manufacturing plant in san diego, ca. The t:slim g4 insulin pump is a component of the dexcom g4 platinum cgm system. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.
| Device | T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM |
| Classification Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Generic Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Applicant | Tandem Diabetes Care, Inc. |
| Date Received | 2016-06-23 |
| Decision Date | 2016-07-20 |
| PMA | P140015 |
| Supplement | S010 |
| Product Code | OYC |
| 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 | Tandem Diabetes Care, Inc. 11045 Roselle Street san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140015 | | Original Filing |
| S029 |
2019-11-20 |
30-day Notice |
| S028 |
2019-01-16 |
30-day Notice |
| S027 |
2018-09-27 |
30-day Notice |
| S026 |
2018-09-12 |
30-day Notice |
| S025 |
2018-02-01 |
Real-time Process |
| S024 |
2018-01-17 |
Real-time Process |
| S023 |
2018-01-16 |
30-day Notice |
| S022 |
2017-05-16 |
30-day Notice |
| S021 |
2017-04-03 |
Normal 180 Day Track No User Fee |
| S020 |
2017-03-01 |
Panel Track |
| S019 |
2017-01-17 |
30-day Notice |
| S018 |
2016-12-23 |
30-day Notice |
| S017 |
2016-12-21 |
Real-time Process |
| S016 |
2016-12-12 |
Real-time Process |
| S015 |
2016-08-23 |
30-day Notice |
| S014 |
2016-08-10 |
30-day Notice |
| S013 |
2016-08-03 |
30-day Notice |
| S012 |
2016-07-12 |
Real-time Process |
| S011 |
2016-07-11 |
Real-time Process |
| S010 |
2016-06-23 |
30-day Notice |
| S009 |
2016-06-09 |
30-day Notice |
| S008 |
2015-12-30 |
30-day Notice |
| S007 |
2015-12-30 |
30-day Notice |
| S006 |
2015-12-29 |
Real-time Process |
| S005 |
2015-09-18 |
30-day Notice |
| S004 |
2015-09-11 |
30-day Notice |
| S003 |
2015-09-11 |
30-day Notice |
| S002 |
2015-09-11 |
30-day Notice |
| S001 |
2015-09-11 |
30-day Notice |
NIH GUDID Devices