DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S037 · decided 2015-09-23
Approval details
- PMA number
- P120005
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2015-07-16
- Decision date
- 2015-09-23
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS.
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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 |