|
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 | S055 |
Date Received | 02/01/2022 |
Decision Date | 03/02/2022 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternate manufacturing site for the manufacture of a sensor membrane polymer component. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System. |