FDA.reportPublic FDA data

PMA P150001S077

Device
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S077
Product code
OZO
Decision date
2019-11-15
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom.

Current openFDA PMA Record#

Device
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S077
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2019-11-15
Decision code
OK30
Date received
2019-10-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom.