As to my original post, while the non-recommendation for approval may not be an outright rejection, it's very, every seldom that the FDA will not comply with the recommendation of the panel, particularly when the need is already being met with an existing product.
Don't get me wrong, I'm long ABT and have been for years, but this is not promising as far as an eventual approval goes.
Now, as to Blurtsy: You're regressing. I thought you gave up stalking me around the internet? What's the matter, I'm not paying enough attention to you and you're getting jealous?. Don't get me wrong, I'm flattered that you're infatuated with me, but try to add something meaningful rather than just prattling on about things you know nothing about, aren't familiar with, or of which you are just plain ignorant. For your information as well, Blurts, this is a device that would be used by an interventional cardiologist or a cardiac surgeon, rather than by a cardiologist.
No, it was not rejected, but just not recommended for approval, pending completion of studies. That's a very different thing from rejection. The news may well be related to the drop, but it's only a short term setback. I'm betting they will eventually get approval, initially for inoperable cases, later for all.