FDA.reportPublic FDA data

PMA P150001S091

Device
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S091
Product code
OZO
Decision date
2021-07-07
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Addition of a second production line for Next Generation Pump (NGP) motors at Medtronics current supplier. The NGP motors are components of the MiniMed 630G and MiniMed 670G Insulin Pumps.

Current openFDA PMA Record#

Device
MiniMed 630G System
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S091
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2021-07-07
Decision code
OK30
Date received
2021-06-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a second production line for Next Generation Pump (NGP) motors at Medtronics current supplier. The NGP motors are components of the MiniMed 630G and MiniMed 670G Insulin Pumps.