FREESTYLE NAVIGATOR
FDA premarket approval P050020/S003 · decided 2008-05-21
Approval details
- PMA number
- P050020
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FREESTYLE NAVIGATOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2008-04-21
- Decision date
- 2008-05-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- APPROVAL FOR TWO LABELING MODIFICATIONS: 1) TO MODIFY A WARNING REGARDING USE OF THE SYSTEM IN AN ENVIRONMENT WHERE ANESTHETIC GAS IS USED TO INSTEAD WARN AGAINST USE IN ENVIRONMENTS THAT CONTAIN ANY COMBUSTIBLE GAS; AND 2) TO ADD LANGUAGE TO THE INSTRUCTIONS FOR MUTING ALARMS TO CLARIFY WHEN IT IS NOT RECOMMENDED TO DO SO AND ALSO TO CLARIFY WHEN THE SYSTEM WILL GO INTO ABANDON ALARM MODE WHEN THE ALARMS ARE MUTED.
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