PMA P160017S099

Device: Medtronic MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S099
Product code: OZP
Decision date: 2022-04-28
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Addition of an alternate supplier of a raw material used in the manufacture of the CONTOUR NEXT test strips. The test strip is a component of the MiniMed 630G and MiniMed 670G systems.

Current openFDA PMA Record#

Device: Medtronic MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S099
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2022-04-28
Decision code: OK30
Date received: 2022-03-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate supplier of a raw material used in the manufacture of the CONTOUR NEXT test strips. The test strip is a component of the MiniMed 630G and MiniMed 670G systems.