PMA P150001S097

Device: Medtronic MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S097
Product code: OZO
Decision date: 2022-04-28
Generic name: Automated insulin dosing , threshold suspend
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 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S097
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
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.