DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S031 · decided 2015-05-22
Approval details
- PMA number
- P120005
- Supplement
- S031
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2014-11-26
- Decision date
- 2015-05-22
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE DEXCOM G4¿ PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4
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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 |