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PMA P160007S030

Device
Guardian Connect system
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S030
Product code
MDS
Decision date
2019-12-19
Generic name
Sensor, glucose, invasive
Approval order statement
Changes to the bonding of the sensor to sensor base for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System.

Current openFDA PMA Record#

Device
Guardian Connect system
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S030
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
Changes to the bonding of the sensor to sensor base for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System.