|
Device | FreeStyle Libre Pro Flash Glucose Monitoring System |
Generic Name | Sensor, glucose, invasive |
Applicant | Abbott Diabetes Care Inc. 1360 SOUTH LOOP RD. ALAMEDA, CA 94502 |
PMA Number | P150021 |
Supplement Number | S031 |
Date Received | 06/18/2018 |
Decision Date | 07/03/2018 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alternate electrostatic discharge (ESD) suppressor components for the Reader of the FreeStyle Libre Flash Glucose Monitoring System and the Reader of the FreeStyle Libre Pro Flash Glucose Monitoring System, to support higher manufacturing capacity. |