FreeStyle Libre Pro Flash Glucose Monitoring System
FDA premarket approval P150021/S031 · decided 2018-07-03
Approval details
- PMA number
- P150021
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Diabetes Care, Inc.
- Date received
- 2018-06-18
- Decision date
- 2018-07-03
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- Approval for alternate electrostatic discharge (ESD) suppressor components for the Reader of the FreeStyle Libre Flash Glucose Monitoring System and the Reader of the FreeStyle Libre Pro Flash Glucose Monitoring System, to support higher manufacturing capacity.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K233537) | Abbott Diabetes Care, Inc. | 2024-04-23 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K223435) | Abbott Diabetes Care, Inc. | 2023-04-13 |
| FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447) | Abbott Diabetes Care, Inc. | 2023-03-03 |
| FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537) | Abbott Diabetes Care, Inc. | 2023-02-21 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K212132) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) | Abbott Diabetes Care, Inc. | 2021-11-22 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K211102) | Abbott Diabetes Care, Inc. | 2021-08-11 |