t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
FDA premarket approval P140015/S029 · decided 2019-12-19
Approval details
- PMA number
- P140015
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Applicant
- Tandem Diabetes Care, Inc.
- Date received
- 2019-11-20
- Decision date
- 2019-12-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OYC
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Control-IQ+ technology (K260429) | Tandem Diabetes Care, Inc. | 2026-04-24 |
| Tandem Mobi insulin pump with interoperable technology (K253074) | Tandem Diabetes Care, Inc. | 2025-11-06 |
| t:slim X2 insulin pump with interoperable technology (K250792) | Tandem Diabetes Care, Inc. | 2025-09-24 |
| Control-IQ+ technology (K250798) | Tandem Diabetes Care, Inc. | 2025-05-21 |
| Control-IQ+ technology (K243823) | Tandem Diabetes Care, Inc. | 2025-02-24 |
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| Tandem Mobi insulin pump with interoperable technology (K240309) | Tandem Diabetes Care, Inc. | 2024-03-21 |
| t:slim X2 Insulin Pump with Interoperable Technology (K232380) | Tandem Diabetes Care, Inc. | 2023-11-03 |