|
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 | S012 |
Date Received | 09/25/2017 |
Decision Date | 03/20/2018 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Flextronics Manufacturing Aguascalientes, Boulevard a Zacatecas Km. 9.5 Jesus Maria, Aguascalientes, Mexico 20900 for final assembly of the Freestyle Libre Pro Reader |