DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S036 · decided 2015-07-02
Approval details
- PMA number
- P120005
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2015-05-14
- Decision date
- 2015-07-02
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR SOFTWARE MODIFICATIONS TO THE EXISTING FIRMWARE UPDATE TOOL TO ALLOW THE TOOL TO BE RUN ON MAC OS X OPERATING SYSTEMS, TO IMPROVE THE RUNTIME AND SIMPLIFY INSTALLATION STEPS ON CURRENTLY SUPPORTED WINDOWS PLATFORMS, TO ADD NOTIFICATIONS WHICHALERT USERS COMPATIBILITY ISSUES WITH USB 3.0 PORTS, AND TO IMPROVE COMPATIBILITY WITH FUTURE DEXCOM PRODUCTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Stelo Glucose Biosensor System (K260935) | Dexcom, Inc. | 2026-06-12 |
| Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (K261402) | Dexcom, Inc. | 2026-06-08 |
| Stelo Glucose Biosensor System (K261359) | Dexcom, Inc. | 2026-05-21 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253737) | Dexcom, Inc. | 2026-02-03 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253710) | Dexcom, Inc. | 2025-12-17 |
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| Dexcom G7 15 Day Continuous Glucose Monitoring System (K243214) | Dexcom, Inc. | 2025-04-09 |
| Dexcom G7 Continuous Glucose Monitoring System (K240902) | Dexcom, Inc. | 2024-04-23 |