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PMA P150001S079

Device
MiniMed 630G System With SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S079
Product code
OZO
Decision date
2019-12-19
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Adding a new Chemical Vapor Deposition (CVD) line to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor is a component of the Guardian Connect, MiniMed 630G, and MiniMed 670G systems.

Current openFDA PMA Record#

Device
MiniMed 630G System With SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S079
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
Adding a new Chemical Vapor Deposition (CVD) line to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor is a component of the Guardian Connect, MiniMed 630G, and MiniMed 670G systems.