FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P050020/S008 · decided 2009-10-29

Approval details

PMA number: P050020
Supplement: S008
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic name: Sensor, glucose, invasive
Applicant: Abbott Laboratories
Date received: 2008-11-28
Decision date: 2009-10-29
Days to decision: 335 days
Decision code: APPR
Product code: MDS
Advisory committee: Clinical Chemistry
Expedited review: No
Location: Alameda, CA
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 AN

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