Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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)...

You may also be interested in...

Broad Coverage For Lap-Band Helps Grow Allergan’s Obesity Sales

CMS' decision to cover Allergan's Lap-Band laparoscopic adjustable gastric band for Medicare beneficiaries last February helped spark a 33% revenue jump for Allergan's obesity intervention business in 2006

Building Trust In Brands Should Be A Continuous Process For The Self-Care Industry

“You can’t just live off the brand equity anymore,” warned J&J's Consumer Health's Minoj Raghunandanan during the ‘Advancing Trust in the Self-Care Industry’ webinar co-hosted by the Global Self-Care Federation and HBW Insight. “You’ve got to continue to build that trust between consumers and products day-in day-out.”

AAM Welcomes Proposal To Update Medicare Part D

After urging the US Congress to act on updating Medicare Part D, the Association for Accessible Medicines has welcomed the decision to update Part D by the Centers for Medicare & Medicaid Services of the US Department of Health and Human Services.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts