FDA.reportPublic FDA data

PMA P120010S114

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S114
Product code
OZO
Decision date
2018-04-10
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
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
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S114
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
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.