DEXCOM CGM
FDA premarket approval P050012/S045 · decided 2012-08-17
Approval details
- PMA number
- P050012
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM CGM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2012-02-21
- Decision date
- 2012-08-17
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TREN
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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 |