Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

FDA Panel Narrowly Supports BioMimetic's Augment Synthetic Bone Graft

This article was originally published in The Gray Sheet

Executive Summary

FDA's Orthopedic and Rehabilitation Devices advisory panel narrowly supported approval of BioMimetic Therapeutics’ Augment synthetic bone graft May 12.

You may also be interested in...



Wright Medical Augments Ortho Extremities Biz With BioMimetic Purchase

Firm expects to gain PMA approval in 2013 for BioMimetic’s Augment bone graft as a replacement for autologous bone graft in foot and ankle fusion procedures. Deal includes $190 million down, and up to $190 million more in milestone payments.

BioMimetic Amends Augment Bone Graft PMA, Expects Approval By 2014

BioMimetic Therapeutics submits PMA amendment for its Augment bone graft device to address questions raised by FDA in a “not approvable” letter disclosed in January.

New Products In Brief

Boston Scientific’s TruePath for chronic total occlusions in the peripheral vasculature, Medtronic’s DF4 ICD/CRT-D lead connector, and Toshiba’s Aquilion Prime computed tomography system are among new products on the market.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

MT030137

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

Cancel