Dexcon Seven And Seven Plus
FDA PMAClass III (US FDA PMA)
by Dexcom, Inc.
Identity
- Trade Name
- DEXCOM STS CONTINOUS MONITORS FDA PMA
- Generic Name
- Sensor, glucose, invasive FDA PMA
Identifiers
- PMA Number
- P050012 FDA PMA
- FDA Product Code
- MDS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Clinical Chemistry FDA PMA
- FDA Decision
- APWD FDA PMA
The Dexcom Seven and Seven Plus are invasive glucose sensors designed for continuous monitoring of blood glucose levels in adults aged 18 and older with diabetes. Classified as a Class III medical device, these systems detect trends and track glucose patterns to aid in managing hyperglycemia and hypoglycemia, complementing—but not replacing—standard glucose monitoring devices. The devices are intended for use in both home and healthcare facility settings, providing real-time data to inform acute and long-term therapy adjustments.
These systems are supplied as prescription-use devices and are approved under FDA PMA (P050012). The Dexcom Seven Plus extends use duration to seven days, while the original Seven supports up to three days. Both are single-use, non-sterile devices intended for subcutaneous implantation and are regulated under the product code MDS. Storage and handling follow manufacturer guidelines to ensure proper functionality and accuracy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dexcom - Wikipedia, Dexcom CGM - Wikipedia, DEXCOM SEVEN PLUS USER MANUAL Pdf Download | ManualsLib, Who Makes Dexcom: The Company Behind G7, Stelo, and the CGM
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050012 | Class III | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA PMA P050012 24 fields · synced Sep 18, 2026