|
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 | S017 |
Date Received | 12/01/2017 |
Decision Date | 12/29/2017 |
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 Addition of a new injection molding machine and an alternative higher cavitation (16-cavity) mold tool for the sensor applicator housing component of the Freestyle Libre Flash Glucose Monitoring System and the FreeStyle Libre Pro Flash Glucose Monitoring System. |