93580 FDA Approved?

Does anyone know if the PFO Closure procedure (93580) FDA Approved? BCBS is denying one stating that it is not FDA Approved. That seems wrong. Does anyone know?
Thank you

Mar 15th, 2010 -

It's a mistake if your patient met criteria

http://www.empireblue.com/provider/noapplication/f2/s5/t9/pw_ad084961.pdf