PMA P160030S032
- Device
- FreeStyle Libre 14day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S032
- Product code
- PZE
- Decision date
- 2019-03-04
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Approval order statement
- Additional manufacturing and assembly line for a component of the FreeStyle Libre sensor pack. The sensor pack is a component of the FreeStyle Libre and FreeStyle Libre Pro Flash Glucose Monitoring Systems.
Current openFDA PMA Record#
- Device
- FreeStyle Libre 14day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S032
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2019-03-04
- Decision code
- OK30
- Date received
- 2019-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional manufacturing and assembly line for a component of the FreeStyle Libre sensor pack. The sensor pack is a component of the FreeStyle Libre and FreeStyle Libre Pro Flash Glucose Monitoring Systems.