FDAnews Device Daily Bulletin

J&J Submits PMA Application for Obesity Device

April 12, 2007

Johnson & Johnson (J&J) announced it submitted a premarket approval (PMA) application for its adjustable gastric band, an implantable device to treat morbid obesity.

The device is a soft, adjustable band that is fitted around the uppermost part of the stomach during laparoscopic surgery, creating a small pouch and restricting food consumption, the company said.

The company's submission includes results from a multicenter trial evaluating the safety and effectiveness of the device, which has been commercially available outside the U.S. since 1996. It has been implanted in more than 100,000 patients worldwide, according to J&J.