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Re: Flenderson post# 14437

Monday, 10/06/2014 6:06:54 PM

Monday, October 06, 2014 6:06:54 PM

Post# of 140486
This has been a point I had been making in the past as well. With increased scrutiny of daVinci it is not out of tve realm of possibility that the FDA bump these devices up to Class III status. This would require a PMA and US clinical trials to support safety/efficacy. Very small chance of it happening, but if so, the process will be slowed significantly.