PMA P160017S134

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S134
Product code: OZP
Decision date: 2025-12-08
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: a change to the patch bonding equipment of Simplera and Simplera Sync sensors. The Simplera Sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G systems

Current openFDA PMA Record#

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S134
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-12-08
Decision code: OK30
Date received: 2025-11-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the patch bonding equipment of Simplera and Simplera Sync sensors. The Simplera Sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G systems