PMA P050020S021
- Device
- Freestyle Navigator Continuous Glucose Monitoring
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S021
- Decision date
- 2010-01-11
Current openFDA PMA Record
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S021
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-01-11
- Decision code
- APPR
- Date received
- 2009-12-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES FOR THE FREESTYLE NAVIGATOR USER¿S GUIDE AS FOLLOWS: 1) ADDITION OF THE STATEMENT UNDER THE ¿SPECIFICATIONS¿ SECTION¿ ¿STORE THE TEST STRIPS BETWEEN 40 DEGREES F AND 86 DEGREES F.¿; 2) ADDITION OF THE STATEMENT UNDER THE ¿IMPORTANT NOTES¿ SECTION: ¿THE SYSTEM IS INTENDED FOR YOUR PERSONAL USE; DO NOT SHARE YOUR SYSTEM WITH OTHERS.¿