DEXCOM SEVEN SYSTEMS
FDA premarket approval P050012/S018 · decided 2009-05-05
Approval details
- PMA number
- P050012
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM SEVEN SYSTEMS
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2009-03-09
- Decision date
- 2009-05-05
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM. THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC). THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIF
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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 |