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PMA P150001S046

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S046
Product code
OZO
Decision date
2018-06-28
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.

Current openFDA PMA Record#

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S046
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2018-06-28
Decision code
APPR
Date received
2018-06-07
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.