PMA P160017S098

Device: Medtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S098
Product code: OZP
Decision date: 2022-04-28
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Manufacturing changes for the next generation pump (NGP) case assembly. The NGP case assembly is a component of the Medtronic MiniMed 630G, 670G, and 770G insulin pump systems.

Current openFDA PMA Record#

Device: Medtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S098
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2022-04-28
Decision code: OK30
Date received: 2022-03-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing changes for the next generation pump (NGP) case assembly. The NGP case assembly is a component of the Medtronic MiniMed 630G, 670G, and 770G insulin pump systems.