PMA 160017 covers the FDA Premarket Approval for Medtronic MiniMed’s advanced insulin delivery systems, including the MiniMed 670G and MiniMed 780G. These automated insulin pumps represent significant innovations in diabetes management, combining continuous glucose monitoring with smart insulin delivery algorithms to help maintain optimal glucose control.
The original approval under PMA 160017 applied to the MiniMed 670G, and has since been expanded through a series of supplemental approvals (S-numbers) to encompass technology upgrades and newer models such as the MiniMed 780G. As Class III medical devices, both systems underwent the FDA’s most stringent review process to ensure their safety, reliability, and clinical effectiveness.
Key Details:
PMA Number: 160017
Devices Covered: MiniMed 670G and MiniMed 780G Insulin Pump Systems
Manufacturer: Medtronic MiniMed, Inc.
Device Type: Automated Insulin Delivery System
Function: Continuously monitors glucose levels and automatically adjusts insulin delivery
Regulatory Pathway: FDA Premarket Approval (Class III)
Total pages: 1,000 Fully redacted pages: 871 Content pages: 129
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