PMA P160017S051

Device
MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S051
Product code
OZP
Decision date
2018-11-29
Classification
Automated Insulin Dosing Device System, Single Hormonal Control
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Approval for a minor software design change to fix an anomaly in the main application software used in a specific hardware configuration.

Current openFDA PMA Record#

Device
MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S051
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2018-11-29
Decision code
APPR
Date received
2018-08-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor software design change to fix an anomaly in the main application software used in a specific hardware configuration.