Medtronic Navigation, Inc. - March 5, 2014
Issue Date
Mar 05, 2014
Region
Southwest
Category
Device
$117.00
Contact Name
Scott R. Hutton
Contact Title
VP and General Manager, Neurosurgery
Address 1
826 Coal Creek Cir.
City
Louisville
State
CO
Zip/Postal Code
80027-9710
Country
United States
Inspection Range
Jan 30, 2014 - Feb 19, 2014
Pages
7
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Ashleigh P. Barkans, Laura B. Kennedy, and Amanda S. Zorn