PMA P160017S106

Device: MiniMed 670G System, MiniMedTM 770G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S106
Product code: OZP
Decision date: 2022-12-16
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval for adding supplemental labeling information to the current instructions for use (IFU) for the Medtronic MiniMed 630G, 670G, and 770G Pump Systems.

Current openFDA PMA Record#

Device: MiniMed 670G System, MiniMedTM 770G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S106
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2022-12-16
Decision code: APPR
Date received: 2022-11-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for adding supplemental labeling information to the current instructions for use (IFU) for the Medtronic MiniMed 630G, 670G, and 770G Pump Systems.