PMA P050020S029
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S029
- Product code
- MDS
- Decision date
- 2010-11-23
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO VERIFY THE PRESENCE AND LOCATION OF ADHESIVE CHANNELS IN THE FREESTYLE TEST STRIPS.
Current openFDA PMA Record
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S029
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-11-23
- Decision code
- OK30
- Date received
- 2010-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO VERIFY THE PRESENCE AND LOCATION OF ADHESIVE CHANNELS IN THE FREESTYLE TEST STRIPS.