PMA P050020S010
- Device
- Freestyle Navigator Continuous Glucose Monitoring
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S010
- Decision date
- 2009-09-25
Current openFDA PMA Record
- Device
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- PMA number
- P050020
- Supplement
- S010
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2009-09-25
- Decision code
- APPR
- Date received
- 2009-02-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL NEW PACKAGING AND DESICCANT FOR THE INSERTER SUBCOMPONENT OF THE SENSOR DELIVERY UNIT (SDU), WHICH IS A COMPONENT OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS MODIFICATION TO THE ORIGINAL APPROVED DEVICE RESULTS IN A NEWSTERILIZATION CONFIGURATION, A NEW PACKAGE AND NEW STERILIZATION METHOD (EO) FOR THE SENSORSUPPORT MOUNT SUBCOMPONENT OF THE SDU, USER ASSEMBLY OF THE INSERTER WITH THE SENSOR SUPPORTMOUNT SECTION, NEW SECONDARY CONTAINERS FOR THE SUBCOMPONENTS OF THE SDU SECTION, AND CHANGES TO SDU LABELING CORRESPONDING TO THE PACKAGING CHANGES.