PMA P050020S032
- Device
- Frestyle Navigator Continuous Glucose Monitoring S
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S032
- Decision date
- 2011-05-16
Current openFDA PMA Record
- Device
- FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S032
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2011-05-16
- Decision code
- APPR
- Date received
- 2010-12-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE QUALITY SYSTEM DRAWINGS OF TEN RECEIVER AND TRANSMITTER COMPONENTS, USED FOR FIRST ARTICLE INSPECTION ACTIVITIES PRIOR TO RELEASE FOR MANUFACTURING.