FDA.reportPublic FDA data

PMA P150001S088

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S088
Product code
OZO
Decision date
2020-10-09
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Approval for a design change to the keypad assembly of the Next Generation Pump (NGP), a component of the MiniMed 630G System with SmartGuard and the MiniMed 670G System.

Current openFDA PMA Record#

Device
MiniMed 630G System with SmartGuard
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S088
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2020-10-09
Decision code
APPR
Date received
2020-08-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a design change to the keypad assembly of the Next Generation Pump (NGP), a component of the MiniMed 630G System with SmartGuard and the MiniMed 670G System.