FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S021 · decided 2010-01-11
Approval details
- PMA number
- P050020
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2009-12-22
- Decision date
- 2010-01-11
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- 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.¿
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