Change the procedure for wake button replacement during pcba refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim x2 insulin pump with dexcom g5 mobile cgm and the t:slim insulin pump with basal-iq technology.
| 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 | 2018-09-27 |
| Decision Date | 2018-10-26 |
| PMA | P180008 |
| Supplement | S006 |
| Product Code | OZO |
| 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. 11075 Roselle Street san Diego, CA 92121 |
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