PMA P160017S132

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S132
Product code: OZP
Decision date: 2025-12-05
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: addition of an alternate manufacturing site for the sensor fabrication processes for the 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 780G system

Current openFDA PMA Record#

Device: MiniMed 780G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S132
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-12-05
Decision code: OK30
Date received: 2025-11-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate manufacturing site for the sensor fabrication processes for the 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 780G system