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Medtronic Navigation, Inc. - March 5, 2014

Issue Date

Mar 05, 2014

Region

Southwest

Category

Device
$117.00

Medtronic Navigation, Inc. - March 5, 2014

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