Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- CGMS IPRO SYSTEM
- PMA Number
- P980022
- Supplement Number
- S020
- 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
- January 22, 2008
- Date Received
- June 19, 2007
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE CGMS IPRO SYSTEM. THE CGMS IPRO SYSTEM INCLUDES THE CGMS IPRO DIGITAL RECORDER, SOLUTIONS SOFTWARE FOR CGMS IPRO, COMLINK IPRO, AND CGMS IPRO WAND. THE DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THE INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICE. THE INFORMATION COLLECTED BY THE CGMS IPRO DIGITAL RECORDER MAY BE DOWNLOADED, USING THE COMLINK IPRO, THE SOLUTIONS SOFTWARE FOR CGMS IPRO AND A PERSONAL COMPUTER, AND REVIEWED BY HEALTHCARE PROFESSIONALS. THE INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.
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 |