FDA.reportPublic FDA data

PMA P160017S109

Device
Medtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G)
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S109
Product code
OZP
Decision date
2023-03-13
Classification
Clinical Chemistry
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Manufacturing change to expand the welding parameters used when manufacturing the pump case assembly. The pump case assembly is a component of the MiniMed 630G, MiniMed 670G, and MiniMed 770G systems.

Current openFDA PMA Record#

Device
Medtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G)
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S109
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2023-03-13
Decision code
OK30
Date received
2023-02-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing change to expand the welding parameters used when manufacturing the pump case assembly. The pump case assembly is a component of the MiniMed 630G, MiniMed 670G, and MiniMed 770G systems.