PMA P160017S124

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S124
Product code: OZP
Decision date: 2025-08-29
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval of the MiniMed 780G System for expanding the indications for use to include type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

Current openFDA PMA Record#

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S124
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-08-29
Decision code: APPR
Date received: 2025-04-25
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the MiniMed 780G System for expanding the indications for use to include type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.