FDA 483 - Medtronic Navigation, Inc. - September 30, 2019

Medtronic Navigation, Inc. in Louisville, CO, a medical device manufacturer, was inspected by the FDA. The inspection revealed one observation concerning the firm's failure to recertify a modified laser product, specifically the Visualase™ MRI-Guided Laser Ablation System. This modification, involving software that controls the laser and safety interlocks, required a Product Report and subsequent Annual Reports to FDA.