|
Device | Freestyle Libre 14-Day Flash Glucose Monitoring System |
Generic Name | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP DR. ALAMEDA, CA 94502-7000 |
PMA Number | P160030 |
Supplement Number | S044 |
Date Received | 08/03/2020 |
Decision Date | 11/19/2021 |
Product Code |
PZE |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 |