FDA.reportPublic FDA data

PMA P150001S078

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S078
Product code
OZO
Decision date
2019-12-19
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Changes to the bonding of the sensor to sensor base for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System.

Current openFDA PMA Record#

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S078
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2019-12-19
Decision code
OK30
Date received
2019-11-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the bonding of the sensor to sensor base for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System.