PMA P050020S024
- Device
- Freestyle Navigator Continuous Glucose Monitoring
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S024
- Decision date
- 2010-07-09
Current openFDA PMA Record
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S024
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-07-09
- Decision code
- OK30
- Date received
- 2010-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE INJECTION MOLDED TRAY WHICH PROTECTS THE SENSOR DELIVERY UNIT OF THE DEVICE DURING SHIPPING.