PMA P150001S099

Device: Medtronic MiniMed 630G System with SmartGuard
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S099
Product code: OZO
Decision date: 2022-10-17
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Approval for a labeling update to ensure that users recognize the need to save after setting all basal rate settings on new and replacement MiniMed 630G and 670G Systems.

Current openFDA PMA Record#

Device: Medtronic MiniMed 630G System with SmartGuard
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S099
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2022-10-17
Decision code: APPR
Date received: 2022-09-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling update to ensure that users recognize the need to save after setting all basal rate settings on new and replacement MiniMed 630G and 670G Systems.