- Device
- Freestyle Libre 14 day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S042
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2020-05-21
- Decision code
- APPR
- Date received
- 2020-04-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Tech Group Europe Limited t/a West, Damastown Close, Damastown Industrial Park, Mulhuddart, Dublin 15, D15 K009 Ireland for sensor kit assembly. The sensor kit is a component of the Freestyle Libre 14 day Flash Glucose Monitoring System.