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PMA P150001S082

Device
Medtronic MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S082
Product code
OZO
Decision date
2020-01-31
Generic name
Automated insulin dosing , threshold suspend
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 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S082
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
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.