- Device
- Freestyle Libre 14-day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S040
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2019-12-16
- Decision code
- OK30
- Date received
- 2019-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a 100% in-process check for additional, missing, and/or misplaced springs in the sensor applicator subassembly of the FreeStyle Libre 14-day Flash Glucose Monitoring System and FreeStyle Libre Pro Flash Glucose Monitoring System.