FDA.reportPublic FDA data

PMA P150001S084

Device
MiniMed 630G System with Smart Guard
Applicant
Medtronic Minimed
Product code
OZO
Decision date
2021-01-14
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for manufacturing changes related to sterilization process for Guardian Sensor (3). The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.

Current openFDA PMA Record#

Device
MiniMed 630G System with Smart Guard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S084
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2021-01-14
Decision code
APPR
Date received
2020-05-18
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for manufacturing changes related to sterilization process for Guardian Sensor (3). The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.