FDA.reportPublic FDA data

PMA P160017S082

Device
MiniMed 670G Insulin Pump
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S082
Product code
OZP
Decision date
2020-04-16
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
New reclamation process to allow printed circuit board assemblies to be re-used for construction of refurbished 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.

Current openFDA PMA Record#

Device
MiniMed 670G Insulin Pump
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S082
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2020-04-16
Decision code
OK30
Date received
2020-03-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New reclamation process to allow printed circuit board assemblies to be re-used for construction of refurbished 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.