FDA.reportPublic FDA data

PMA P150021S034

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S034
Product code
MDS
Decision date
2018-09-27
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Addition of a new injection molding machine and an alternate higher cavitation mold tool to increase the product capacity for the sheath component of the Freestyle Libre Pro Flash Glucose Monitoring System.

Current openFDA PMA Record#

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S034
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-09-27
Decision code
OK30
Date received
2018-08-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new injection molding machine and an alternate higher cavitation mold tool to increase the product capacity for the sheath component of the Freestyle Libre Pro Flash Glucose Monitoring System.