PMA P150001S104

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S104
Product code: OZO
Decision date: 2023-04-18
Classification: Clinical Chemistry
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Approval for a minor design change to the Next Generation Pumps (NGP) to remove remote bolus functionality, remove remote settings modification, and disable over the air programming. The proposed changes address vulnerabilities in connection with Field Action (FA1272) and will be implemented in the MiniMed 670G and 630G Insulin Pumps.

Current openFDA PMA Record#

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S104
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2023-04-18
Decision code: APPR
Date received: 2023-01-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a minor design change to the Next Generation Pumps (NGP) to remove remote bolus functionality, remove remote settings modification, and disable over the air programming. The proposed changes address vulnerabilities in connection with Field Action (FA1272) and will be implemented in the MiniMed 670G and 630G Insulin Pumps.