FDA.reportPublic FDA data

PMA P150029S017

Device
iPro2 System
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S017
Product code
MDS
Decision date
2018-04-10
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Adding an alternate injection molding machine and mold to produce the needle hub body component. The changes will apply to the Enlite Sensor and Guardian Sensor (3) which are part of the MiniMed 530G, MiniMed 630G, Paradigm Real-Time Revel, iPro2 CGM, and Medtronic 670G systems.

Current openFDA PMA Record#

Device
iPro2 System
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S017
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-04-10
Decision code
OK30
Date received
2018-03-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate injection molding machine and mold to produce the needle hub body component. The changes will apply to the Enlite Sensor and Guardian Sensor (3) which are part of the MiniMed 530G, MiniMed 630G, Paradigm Real-Time Revel, iPro2 CGM, and Medtronic 670G systems.