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The Dental Products Panel (the Panel) met on Thursday, November 9, 2006 in Gaithersburg, MD, to make a recommendation to the Food and Drug Administration (FDA) on the approvability of Medtronic Sofamor Danek’s (the sponsor) premarket approval application (PMA), P050053) for InFuse ® Bone Graft. InFuse Bone Graft is a combination product consisting of collagen sponge bone void filler combined with a bone morphogenetic protein (rhBMP-2) that is intended to be an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets. The Panel membership for this meeting consisted of two periodontists, two oral surgeons, a toxicologist, a materials engineer, a biostatistician, a device industry representative, a drug industry representative, and a consumer representative.
The sponsor presented its information on the safety and effectiveness of the device and FDA followed with a summary of its clinical and statistical findings. One Panel members, an oral surgeon, led the Panel deliberations with a short presentation. Throughout its deliberations, the Panel considered FDA’s questions for consideration. FDA’s main concerns were whether the possible reduction in morbidity associated with InFuse outweighs the potential reduction in effectiveness for sinus augmentation when compared to autograft, and whether the data submitted for ridge augmentation at tooth extraction sites is sufficient to arrive at a clinically meaningful conclusion with respect to device effectiveness .
The Panel believed that there was a reasonable assurance that the device is safe under the conditions for use. The Panel believed there was a reasonable assurance that the device is effective but only with strict labeling.
The Panel voted 6-0 with no abstentions for “Approval with Conditions.” The condition was as follows:
- The labeling should note that in regards to the ridge augmentation at tooth extraction sites indication, this device has not been tested in the molar region of the mouth, or in the mandible.
The Panel imposed this condition because it believed that it was not clear that the data presented – from the anterior region of the maxilla – demonstrated effectiveness of this device for ridge augmentation at tooth extraction sites throughout the entire mouth.
The Panel adjourned with thanks to the sponsor and the FDA for their presentations.
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