PMA P160017S131

Device: MiniMed 670G system MiniMed 770G system MiniMed 780G system
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S131
Product code: OZP
Decision date: 2025-12-10
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System

Current openFDA PMA Record#

Device: MiniMed 670G system MiniMed 770G system MiniMed 780G system
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S131
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-12-10
Decision code: OK30
Date received: 2025-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System