PMA P050020S008

Device: FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Abbott Laboratories
PMA number: P050020
Supplement: S008
Product code: MDS
Decision date: 2009-10-29
Generic name: Sensor, glucose, invasive
Approval order 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.

Current openFDA PMA Record

Device: FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Abbott Laboratories
PMA number: P050020
Supplement: S008
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2009-10-29
Decision code: APPR
Date received: 2008-11-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.