PMA P160030S027
- Device
- Freestyle Libre Pro
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S027
- Product code
- PZE
- Decision date
- 2018-12-21
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Approval order statement
- Approval for modification of the membrane layer formulation of the FreeStyle Libre and FreeStyle Libre Pro sensor components and an addition of a shipping method for shipment of sensor components.
Current openFDA PMA Record#
- Device
- Freestyle Libre Pro
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S027
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2018-12-21
- Decision code
- APPR
- Date received
- 2018-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification of the membrane layer formulation of the FreeStyle Libre and FreeStyle Libre Pro sensor components and an addition of a shipping method for shipment of sensor components.