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PMA P160017S079

Device
Medtronic MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S079
Product code
OZP
Decision date
2019-12-19
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System.

Current openFDA PMA Record#

Device
Medtronic MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S079
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2019-12-19
Decision code
OK30
Date received
2019-11-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System.