Freestyle Libre 14-Day Flash Glucose Monitoring System
FDA premarket approval P160030/S044 · decided 2021-11-19
Approval details
- PMA number
- P160030
- Supplement
- S044
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Freestyle Libre 14-Day Flash Glucose Monitoring System
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Applicant
- Abbott Diabetes Care, Inc.
- Date received
- 2020-08-03
- Decision date
- 2021-11-19
- Days to decision
- 473 days
- Decision code
- APPR
- Product code
- PZE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- Approval to introduce a new ISO 8 clean room and associated manufacturing equipment to perform sensor component manufacturing at the ADC Witney, UK manufacturing site. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems
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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 |