DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S005 · decided 2013-08-14
Approval details
- PMA number
- P120005
- Supplement
- S005
- 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
- 2013-05-20
- Decision date
- 2013-08-14
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED.
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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 |