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PMA P160007S043

Device
Guardian Sensor 3
Applicant
Medtronic Minimed
Product code
MDS
Decision date
2022-12-16
Generic name
Sensor, glucose, invasive
Approval order statement
Approval for the addition of Medtronic Puerto Rico Operations Co. as a manufacturing site for the sensor fabrication process for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G and 770G Systems, the Guardian Connect System, and the MiniMed 630G System.

Current openFDA PMA Record#

Device
Guardian Sensor 3
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S043
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2022-12-16
Decision code
APPR
Date received
2021-12-09
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of Medtronic Puerto Rico Operations Co. as a manufacturing site for the sensor fabrication process for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G and 770G Systems, the Guardian Connect System, and the MiniMed 630G System.