|
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 | S057 |
Date Received | 04/01/2022 |
Decision Date | 04/28/2022 |
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 Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of the FreeStyle Libre 14-Day and FreeStyle Libre Pro Glucose Monitoring Systems. |