FreeStyle Libre Pro Flash Glucose Monitoring System
FDA premarket approval P150021/S046 · decided 2020-05-12
Approval details
- PMA number
- P150021
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- 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
- 2019-10-18
- Decision date
- 2020-05-12
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- Approval for 1) introducing an alternate adhesive used in the assembly of the sensor puck; 2) introducing an additional sensor puck assembly manufacturing line at an existing manufacturing site; and 3) introducing a new ISO 8 cleanroom in which the additional assembly line will be located. The sensor puck 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 |