|
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 | S049 |
Date Received | 07/01/2020 |
Decision Date | 07/30/2020 |
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 introduction of an alternate supplier for the Sensor Applicator and addition of an inspection step at Abbott Diabetes Care supplier for the sensor component manufacturing process. The Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System |