|
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 | S024 |
Date Received | 03/12/2018 |
Decision Date | 07/23/2018 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
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 design changes to the adhesive pad used in the sensor of the FreeStyle Libre Pro Flash Glucose Monitoring System and FreeStyle Libre Flash Glucose Monitoring System. |