PMA P160017S085

Device
MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S085
Product code
OZP
Decision date
2020-06-25
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Addition of a new piece of manufacturing equipment for CGM sensor coating.

Current openFDA PMA Record#

Device
MiniMed 670G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S085
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2020-06-25
Decision code
OK30
Date received
2020-05-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new piece of manufacturing equipment for CGM sensor coating.