PMA P160017S135

Device
MiniMed 780G System
Applicant
Medtronic Minimed, Inc.
PMA number
P160017
Supplement
S135
Product code
OZP
Decision date
2026-06-12
Classification
Clinical Chemistry
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.