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PMA P160007S031

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S031
Product code
MDS
Decision date
2019-12-19
Generic name
Sensor, glucose, invasive
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
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S031
Product code
MDS
Generic name
Sensor, glucose, invasive
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.