Approval for the t:slim g4 insulin pump with dexcom g4 platinum cgm (¿t:slim g4 system¿). This device consists of the t:slim g4 insulin pump paired with the dexcom g4 platinum sensor and transmitter. The t:slim g4 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim g4 insulin pump can be used solely for continuous insulin delivery and as part of the t:slim g4 system to receive and display continuous glucose measurements from the dexcom g4 platinum sensor and transmitter. The t:slim g4 system also includes continuous glucose monitoring (cgm) indicated for detecting trends and tracking patterns in persons with diabetes for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The t:slim g4 system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim g4 system results should be based on the trends and patterns seen with several sequential readings over time. The t:slim g4 system is indicated for use in individuals 12 years of age and greater. The t:slim g4 system is intended for single patient use and requires a prescription.
| Device | T:SLIM G4 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 | 2014-07-17 |
| Decision Date | 2015-09-08 |
| Notice Date | 2015-10-15 |
| PMA | P140015 |
| Supplement | S |
| Product Code | OYC |
| Docket Number | 15M-3376 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Tandem Diabetes Care, Inc. 11045 Roselle Street san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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