Issued: 9/7/11
Region: Pacific
Category: Device 483s
Inspection date range: 8/22/11-9/7/11
Pages: 5
Company: Thoratec Corp.
6035 Stoneridge Dr.
Pleasanton, CA 94588
Inspector(s): Lydia S. Chan, Eric W. Anderson
Observations: A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
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