Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
- PMA Number
- P050020
- Supplement Number
- S008
- 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
- October 29, 2009
- Date Received
- November 28, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFICATION TO THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSEMONITORING SYSTEM RECEIVER SOFTWARE. THE PRIMARY PURPOSE OF THE NEW SOFTWARE IS TO ALLOW USERS TO OBTAIN CONTINUOUS GLUCOSE DATA AS QUICKLY AS POSSIBLE AFTER INSERTION OF THE SENSOR. THE NEWALGORITHM CHANGES THE CALIBRATION TIME TO 1, 2, 10, 24 AND 72 HOURS, WITH GLUCOSE DATA BEINGAVAILABLE AT ONE HOUR. OTHER CHANGES ARE THE INCREASE TO ALLOWABLE RANGE FOR GLUCOSE CALIBRATION,INCREASE TO THE ALLOWABLE GLUCOSE RATE CHANGE AND THE ADDITION OF A CALIBRATION LAG CORRECTION.ADDITIONAL CHANGES WERE MADE TO THE RECEIVER SOFTWARE/USER INTERFACE; THE BACKLIGHT WILL NOWALWAYS BE ON WHEN THE RECEIVER IS DISPLAYING INFORMATION, THE SCREEN TIMEOUT WILL BE 20 SECONDS AND THERE WILL BE NO ABANDON ALARM FEATURE.
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 |