PMA P160017

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S106
Product code
OZP
Decision date
2026-06-12
Generic name
Automated insulin dosing device system, single hormonal control
Approval order statement
Approval for updating the sensor compressor dimensions in the Synergy Sensor (Simplera) assembly.

Current openFDA PMA Record#

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S135
Product code
OZP
Generic name
Automated insulin dosing device system, single hormonal control
Decision date
2026-06-12
Decision code
APPR
Date received
2026-01-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updating the sensor compressor dimensions in the Synergy Sensor (Simplera) assembly.