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PMA P160017S081

Device
Medtronic MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S081
Product code
OZP
Decision date
2020-01-31
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
New sterilization site for the sterilization of the Guardian Sensor (3) continuous glucose monitoring sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.

Current openFDA PMA Record#

Device
Medtronic MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S081
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2020-01-31
Decision code
OK30
Date received
2020-01-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New sterilization site for the sterilization of the Guardian Sensor (3) continuous glucose monitoring sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system.