PMA P050020
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S036
- Product code
- MDS
- Decision date
- 2011-07-06
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- UPDATE TO THEIR FIRST ARTICLE INSPECTION (FAI) PROCEDURE.
Current openFDA PMA Record#
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S036
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2011-07-06
- Decision code
- OK30
- Date received
- 2011-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE TO THEIR FIRST ARTICLE INSPECTION (FAI) PROCEDURE.