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

Source: https://www.keypedia.com/records/483/medtronic-navigation-inc/ae3eb485-2ab8-45ef-a5ee-fbe1e90bd18e

> FDA 483 for Medtronic Navigation, Inc. on September 30, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medtronic Navigation, Inc.
- Inspection Date: 2019-09-30
- Product Type: device
- Office Name: FDA District Office — Denver, Colorado
- Summary: 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.

## Related Documents

- [483 - 2021-06-29](https://www.keypedia.com/records/483/medtronic-navigation-inc/42917bc7-112a-4777-b1e7-9b5d9027e7dd)
- [483 - 2024-02-09](https://www.keypedia.com/records/483/medtronic-navigation-inc/2257c687-308f-4fb5-8038-1dc088a57884)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/medtronic-navigation-inc/db526b6e-13be-4d9c-9a9b-d2bfa6db5ddf

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0