PMA P160017S120

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S120
Product code
OZP
Decision date
2024-10-07
Classification
Clinical Chemistry
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
the addition of supplemental labeling information regarding the proper identification of the compatible battery cap for the 780G pump case

Current openFDA PMA Record#

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S120
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2024-10-07
Decision code
APPR
Date received
2024-09-11
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
the addition of supplemental labeling information regarding the proper identification of the compatible battery cap for the 780G pump case