PMA P160017S129

Device: MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S129
Product code: OZP
Decision date: 2025-10-02
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval for changes to the labeling to include formatting changes and new warnings for battery depletion, delivery volume accuracy during air travel, and pump to infusion set distance.

Current openFDA PMA Record#

Device: MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S129
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2025-10-02
Decision code: APPR
Date received: 2025-09-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the labeling to include formatting changes and new warnings for battery depletion, delivery volume accuracy during air travel, and pump to infusion set distance.