FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S013 · decided 2009-04-09
Approval details
- PMA number
- P050020
- Supplement
- S013
- Supplement type
- Real-Time Process
- 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
- 2009-03-20
- Decision date
- 2009-04-09
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- APPROVAL FOR AN UPDATED VERSION OF THE COPILOT HEALTH MANAGEMENT SYSTEM FOR FREESTYLE NAVIGATOR LABELING AND HELP FILES IN THE APPLICATION TO ADD WINDOWS VISTA AS AN OPERATING SYSTEM THAT THE APPLICATION CAN BE INSTALLED ON AS WELL AS ADDING THE NECESSARY STEPS TO ALLOW THE APPLICATION AND DEVICE TO BE USED WITH VISTA.
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