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PMA P160007S002

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S002
Product code
MDS
Decision date
2018-04-20
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Additional laser cutting equipment for manufacture of the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, the Guardian Connect System, and the MiniMed 670G System.

Current openFDA PMA Record#

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S002
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-04-20
Decision code
OK30
Date received
2018-03-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Additional laser cutting equipment for manufacture of the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, the Guardian Connect System, and the MiniMed 670G System.