Gee Sano, why would you think? The FDA is dotting i's and crossing t's. Do you really think they would ignore the company's manufacturing capability even if it is for another product? It would be pretty embarrassing if they approved a device then later found out the company had shoddy manufacturing controls for existing products, don't you think?
Polk or someone posted the "audit" was six months earlier than is normal signaling the likelihood of i-dotting and t-crossing. given all the criticism the FDA has had it only makes sense for them to do this out-of-cycle audit of the company. Approval has been signaled.