FDA.reportPublic FDA data

PMA P150029S023

Device
MiniMed iPro2 CGM System with Enlite Sensor
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S023
Product code
MDS
Decision date
2018-11-30
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.

Current openFDA PMA Record#

Device
MiniMed iPro2 CGM System with Enlite Sensor
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S023
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-11-30
Decision code
OK30
Date received
2018-11-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect systems.