DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S055 · decided 2016-12-09
Approval details
- PMA number
- P120005
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2016-09-14
- Decision date
- 2016-12-09
- 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 firmware modifications to the receiver component in the following Dexcom Continuous Glucose Monitoring Systems: G4 PLATINUM, G4 PLATINUM (Professional), G4 PLATINUM with Share, and G4 PLATINUM with Share for Pediatrics.
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| 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 |
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| 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 |