Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- CARELINK PERSONAL SOFTWARE
- PMA Number
- P980022
- Supplement Number
- S033
- 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
- September 24, 2008
- Date Received
- August 18, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO THE CARELINK PERSONAL THERAPYMANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THE CARELINK PERSONAL THERAPY MANAGEMENTSOFTWARE FOR DIABETES IS A NETWORK BASED SOFTWARE SYSTEM RESIDING ON A COMPUTER SERVER PLATFORM CONNECTED TO THE INTERNET. THE PURPOSE OF THIS SYSTEM IS TO TAKE INFORMATION TRANSMITTED FROM INSULIN PUMPS, CONTINUOUS GLUCOSE MONITORS AND GLUCOSE METERS, AND LOGBOOK DATA ENTERED BY THE PATIENT, AND TURN IT INTO MEDTRONIC CARELINK THERAPY MANAGEMENT SOFTWARE FOR DIABETES REPORTS.THE REPORTS PROVIDE INFORMATION THAT CAN BE USED TO IDENTIFY TRENDS AND TRACK DAILY ACTIVITIES; SUCH AS CARBOHYDRATES EATEN, MEAL TIME, INSULIN DELIVERY, AND BLOOD GLUCOSE READINGS. THE SOFTWAREVERSION 4.6 IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS, WHICH INCLUDE A LOGBOOKDIARY REPORT, REMOVAL OF ROCHE ACCU-CHECK 'AVIVA' AND COMPACT PLUS METERS FROM METERLISTINGS DISPLAYED FOR USERS LOCATED IN COUNTRIES OTHER THAN U.S. AND CANADA, AND CONSOLIDATION OF THE HELP SYSTEM THAT SERVES AS INSTRUCTIONS FOR USE.
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 |