Thoratec Corp. - Nov. 23, 2015
Issue Date
Nov 23, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Chris T. Christoforou
Contact Title
Vice President of Operational Quality and Reliability
Address 1
6035 Stoneridge Dr.
City
Pleasanton
State
CA
Zip/Postal Code
94588-3270
Country
United States
Inspection Range
Nov 10, 2015 - Nov 23, 2015
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Adam S. Freeman