|
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 | S008 |
Date Received | 05/19/2017 |
Decision Date | 11/16/2017 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the manufacturing process to facilitate an increase in the Sensor Kit manufacturing capacity by implementing new high volume (HV) assembly lines for the Printed Circuit Board Assembly (PCBA), Sensor Applicator, and Sensor Container processes. |