(b)(6).Device has not been reported as explanted.Device history record review: documentation shows this device was manufactured, etched, inspected, cleaned and forward for plasma treatment as per model specifications.No inconsistencies were found during these processes.There were no non-conformance reports issued against this work order.Date of release to warehouse was 24 december 2014.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|