Approval for the use of the t:slim x2 insulin pump with basal-iq technology. This device is indicated as follows:the t:slim x2 insulin pump with basal-iq technology (the system) consists of the t:slim x2 insulin pump which contains the basal-iq technology, and a continuous glucose monitor (cgm). Compatible cgms include the dexcom g5 mobile cgm and integrated continuous glucose monitors (icgms) that are listed in the labeling for this device. The t:slim x2 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 x2 insulin pump can be used solely for continuous insulin delivery and as part of the t:slim x2 insulin pump with basal-iq technology system. When the system is used with the dexcom g5 mobile cgm or a compatible icgm, the basal-iq technology can be used to suspend insulin delivery based on cgm sensor readings. The dexcom g5 mobile cgm continuous glucose monitoring system (dexcom g5) is indicated for the management of diabetes in persons age 2 years and older. The dexcom g5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the system results should be based on the trends and patterns seen with several sequential readings over time. The dexcom g5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The dexcom g5 is intended for single patient use and requires a prescription. The system is indicated for use in individuals 6 years of age and greater. The system is intended for single patient use and requires a prescription. The system is indicated for use with novolog or humalog u-100 insulin.
| Device | t:slim X2 Insulin Pump with Basal-IQ Technology |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | Tandem Diabetes Care, Inc. |
| Date Received | 2018-02-26 |
| Decision Date | 2018-06-21 |
| Notice Date | 2018-07-25 |
| PMA | P180008 |
| Supplement | S |
| Product Code | OZO |
| Docket Number | 18M-2462 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Tandem Diabetes Care, Inc. 11075 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 |
|---|
| P180008 | | Original Filing |
| S007 |
2019-11-20 |
30-day Notice |
| S006 |
2018-09-27 |
30-day Notice |
| S005 |
2018-09-12 |
30-day Notice |
| S004 | | |
| S003 |
2018-08-31 |
Real-time Process |
| S002 |
2018-08-31 |
Real-time Process |
| S001 |
2018-08-31 |
Real-time Process |
NIH GUDID Devices