FreeStyle Libre Pro Flash Glucose Monitoring System
FDA premarket approval P150021/S054 · decided 2021-09-30
Approval details
- PMA number
- P150021
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Diabetes Care, Inc.
- Date received
- 2021-09-03
- Decision date
- 2021-09-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- Add an alternate manufacturing site for sensor container assembly and finished sensor kit packing. The sensor container and sensor kit are components of the FreeStyle Libre Pro Flash continuous glucose monitoring (CGM) device
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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 |