DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S009 · decided 2014-10-17
Approval details
- PMA number
- P120005
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2013-07-24
- Decision date
- 2014-10-17
- Days to decision
- 450 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE DEXCOM SHARE SYSTEM AS AN OPTIONAL ACCESSORY OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEXCOM SHARE SYSTEM IS MANUFACTURED AT LEADTEK RESEARCH INC. IN TAIWAN, CHINA.
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510(k) clearances by this applicant
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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 |