FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
FDA premarket approval P050020 · decided 2008-03-12
Approval details
- PMA number
- P050020
- Trade name
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2005-06-08
- Decision date
- 2008-03-12
- Days to decision
- 1008 days
- Decision code
- APWD
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- Yes
- Location
- Alameda, CA
- Statement
- APPROVAL FOR THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEVICE IS INDICATED FOR THE FOLLOWING: THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR CONTINUALLY RECORDING INTERSTITIAL FLUID GLUCOSE LEVELS IN PEOPLE (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. READINGS AND ALARMS ABOUT GLUCOSE LEVELS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM ARE NOT INTENDED TO REPLACE TRADITIONA
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