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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 | S001 |
Date Received | 11/01/2016 |
Decision Date | 06/02/2017 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the adhesive tie layer and the sensor mount components in the Freestyle Libre Pro Flash Glucose Monitoring System Sensor. |