FDA permits marketing of a new device for abdominal surgery
date:May 04, 2012
aroscopic surgery reduces the size and number of incisions needed to perform certain surgical procedures, said Christy Foreman, director of the Office of Device Evaluation in FDAs Center for Devices and Radiological Health. The Percutaneous Surgical Set provides a novel treatment option for performing this type of abdominal procedure.
The FDA reviewed data for the Percutaneous Surgical Set through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices

04/19 20:47