PMA P160017S118

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S118
Product code: OZP
Decision date: 2025-04-18
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval of the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Simplera Sync Sensor.

Current openFDA PMA Record#

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S118
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-04-18
Decision code: APPR
Date received: 2024-04-15
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval of the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Simplera Sync Sensor.