FDA.reportPublic FDA data

PMA P150021S040

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S040
Product code
MDS
Decision date
2019-03-04
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
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.

Current openFDA PMA Record#

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S040
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-03-04
Decision code
OK30
Date received
2019-02-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.