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PMA P150029S034

Device
iPro2 CGM System with Enlite Sensor
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S034
Product code
MDS
Decision date
2019-12-19
Generic name
Sensor, glucose, invasive
Approval order statement
Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System.

Current openFDA PMA Record#

Device
iPro2 CGM System with Enlite Sensor
Applicant
Medtronic Minimed
PMA number
P150029
Supplement
S034
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-12-19
Decision code
OK30
Date received
2019-11-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System.