I have a Pacemaker in my chest Manufactured by Medtronic Devices, there are several other Companies who also manufacture Pacemakers. So the answer they gave you is hogwash. FDA approval works for us and future competitors, we did all the work, and sit like a dummy waiting for someone to notice us, oh they have noticed us and love our strategy. Thanks AW for the pps and volume, your plan is working. JMHO GLTY