PMA P160030S026
- Device
- Freestyle Libre Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S026
- Product code
- PZE
- Decision date
- 2018-09-19
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Approval order statement
- Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.
Current openFDA PMA Record#
- Device
- Freestyle Libre Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S026
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2018-09-19
- Decision code
- OK30
- Date received
- 2018-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.