The FDA doesn't approve procedures, just devices. Apparently they have determined the device is safe. To my mind, that has no bearing on whether or not it will prove effective long term. All it does is make you feel less hungry. I'm not impressed.
Remember that lap band is also FDA approved and has been for years despite the dismal results many people get. People are making lots of money off this device, and probably will with the new device as well, because so many people find the idea of less intervention appealing. But without major lifestyle change, this device won't work, because it doesn't remove weight, it just controls hunger (assuming it works as it is advertised to do - I don't actually know how well or how poorly it works).