This is what I copied from press release dated december 14, 2012.....
the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.
looks like just a request so far...approval probably not far away...jmo
Hmmmm check out the comments at the end of the SA article. Author indicates that Frank said company has received FDA approval.... Whether true or false -- sounds like the Nviv way of doing PR. Of course, hoping it is true.