|
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 | S006 |
Date Received | 04/03/2017 |
Decision Date | 06/23/2017 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Clinical Trials | NCT02073058
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for hardware modifications to the Reader button architecture and for an update to the back label of the Reader. |