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J&J submits gastric band PMA

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson's Ethicon Endo-Surgery subsidiary files a PMA application April 9 for its laparoscopic adjustable gastric band to treat morbid obesity. The FDA submission includes a 276-patient, multi-center, single-arm study examining patients' percent weight loss three years after band placement. The device, marketed outside the United States as the Swedish Adjustable Gastric Band since 1996, is used in 25,000 procedures each year, according to Ethicon. Allergan's Lap-Band, FDA approved in 2001, is the only laparoscopic adjustable gastric band available in the United States (1"The Gray Sheet" March 19, 2007, p. 14)...

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