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PMA P160007S015

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S015
Product code
MDS
Decision date
2019-03-11
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.

Current openFDA PMA Record#

Device
Guardian Connect System
Applicant
Medtronic Minimed
PMA number
P160007
Supplement
S015
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-03-11
Decision code
OK30
Date received
2019-02-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.