>…I remember a case with a medical device for depression (Medtronics) that received a positive recommendation and then was given a non-approvable…<
That was CYBX (not MDT). The incident was notable because CYBX granted its executive officers a boatload of options that were backdated to the day before the panel endorsement.
The device in question does not even work as a treatment for depression, IMHO. It’s nominally on the market, but it’s a non-entity from a commercial standpoint.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”