t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
FDA premarket approval P140015/S021 · decided 2017-12-21
Approval details
- PMA number
- P140015
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Applicant
- Tandem Diabetes Care, Inc.
- Date received
- 2017-04-03
- Decision date
- 2017-12-21
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- OYC
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a manufacturing site change of the t:Slim G4 Insulin Pump, which is used with the Dexcom G4 Platinum CGM, from their old facility at 11045 Roselle St, San Diego, California to their new facility at 10151 Barnes Canyon Rd, San Diego, California.
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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 |