|
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 | S053 |
Date Received | 02/23/2021 |
Decision Date | 09/01/2021 |
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 of a change in the membrane layer polymer of the Libre Sensor. The Libre Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System. |