FDA.reportPublic FDA data

PMA P150001S075

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S075
Product code
OZO
Decision date
2019-10-30
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Addition of a new curing process to increase production capacity of the MiniMed 630G Insulin Pump and the MiniMed670G Insulin Pump. The MiniMedi 630G Insulin pump is a component of the MiniMed 630G System with Smartguard. The MiniMed 670G Insulin Pump is a component of the MiniMed 670G System.

Current openFDA PMA Record#

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S075
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2019-10-30
Decision code
OK30
Date received
2019-09-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new curing process to increase production capacity of the MiniMed 630G Insulin Pump and the MiniMed670G Insulin Pump. The MiniMedi 630G Insulin pump is a component of the MiniMed 630G System with Smartguard. The MiniMed 670G Insulin Pump is a component of the MiniMed 670G System.