DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT
FDA premarket approval P120005/S047 · decided 2016-07-08
Approval details
- PMA number
- P120005
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2016-04-26
- Decision date
- 2016-07-08
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the replacement of the receiver speaker component of the Dexcom G4 PLATINUM/G5 Mobile. Together with the proposed component change, the supplement requested approval of changes to the speaker installation method. The proposed changes occur at Dexcom Inc. as well as OnCore Manufacturing Services, Dexcoms approved supplier. The receiver is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.
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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 |