|Trade Name||INFUSE BONE GRAFT|
|Classification Name||bone grafting material, dental, with biologic component|
|Generic Name||bone grafting material, dental, with biologic component|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the proposed labeling revisions related to the appearance of the reconstituted product and warning statement about use in patients suspected of having cancer at the product application site.