Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- DEXCOM STS CONTINOUS MONITORS
- PMA Number
- P050012
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- March 24, 2006
- Date Received
- March 23, 2005
- Expedited Review
- N
- Docket Number
- 06M-0200
Advisory Committee Statement
APPROVAL FOR THE DEXCOM STS CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEVICE IS INDICATED FOR THE FOLLOWING: 1) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (18 AND OLDER) WITH DIABETES AND IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE. 2) INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. 3) AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE STS SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL SENSOR READINGS OVER TIME.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |