PMA P160017S091

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
Product code: OZP
Decision date: 2023-04-21
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 Guardian 4 Sensor.

Current openFDA PMA Record#

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S091
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2023-04-21
Decision code: APPR
Date received: 2021-02-22
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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 Guardian 4 Sensor.