Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
- PMA Number
- P050012
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 31, 2007
- Date Received
- June 19, 2006
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 07M-0255
Advisory Committee Statement
APPROVAL FOR THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM). THE DEVICE IS INDICATED FOR THE FOLLOWING: THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM) IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THE STS-7 SYSTEM IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM 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-7 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL 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 |