|
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 | S040 |
Date Received | 02/04/2019 |
Decision Date | 03/04/2019 |
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 Additional manufacturing and assembly line for a component of the FreeStyle Libre sensor pack. The sensor pack is a component of the FreeStyle Libre and FreeStyle Libre Pro Flash Glucose Monitoring Systems. |