PMA P150001S102

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S102
Product code: OZO
Decision date: 2022-12-16
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Approval for adding supplemental labeling information to the current instructions for use (IFU) for the Medtronic MiniMed 630G, 670G, and 770G Pump Systems.

Current openFDA PMA Record#

Device: MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S102
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2022-12-16
Decision code: APPR
Date received: 2022-11-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for adding supplemental labeling information to the current instructions for use (IFU) for the Medtronic MiniMed 630G, 670G, and 770G Pump Systems.