After all this time -- submitting all that they (FDA) request, answering their questions, pow-wowing with our Dr.'s and lawyers who (supposedly) have an inside track with these people, Stevie Wonder could see that they just want this equipment to go away. The truth be known, given the LL's widespread acceptance throughout the world, their sanction shouldn't amount to much anyway. BUT, they ARE the FDA and, unfortunately, their approval means something. A freaking Catch 22 if you ask me.