FDA.reportPublic FDA data

PMA P150001S080

Device
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S080
Product code
OZO
Decision date
2019-12-19
Generic name
Automated insulin dosing , threshold suspend
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
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S080
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
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.