U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mix-up rga (return goods authorization) leading to 5 devices being redistributed and implanted 2 patients.
조치
On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number
This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.