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PMA P160017S077

Device
MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S077
Product code
OZP
Decision date
2019-12-19
Generic name
Automated insulin dosing device system, single hormonal control
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 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S077
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
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.