FDA.reportPublic FDA data

PMA P150001S081

Device
MiniMed 630G Insulin Pump
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S081
Product code
OZO
Decision date
2020-01-22
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Modification to an existing harvest/reclaim process for construction of refurbished and loaner 630G and 670G insulin pumps. The 630G and 670G Pumps are components of the MiniMed 630G and MiniMed 670G Systems.

Current openFDA PMA Record#

Device
MiniMed 630G Insulin Pump
Applicant
Medtronic Minimed
PMA number
P150001
Supplement
S081
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2020-01-22
Decision code
OK30
Date received
2019-12-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to an existing harvest/reclaim process for construction of refurbished and loaner 630G and 670G insulin pumps. The 630G and 670G Pumps are components of the MiniMed 630G and MiniMed 670G Systems.