Ethicon Endo-Surgery Inc.’s Sedasys System was granted its appeal by the commissioner’s office of the Food & Drug Administration.
The FDA’s Center for Devices and Radiological Health initially denied the company’s pre-market approval application for the gastroenterology procedure sedation system. The appeal means the FDA will appoint a new advisory committee and hold a public hearing on the device, with a final decision falling to FDA commissioner Dr. Margaret Hamburg.