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Re: notcomnovrjus2chill post# 32427

Tuesday, 05/19/2015 12:39:21 AM

Tuesday, May 19, 2015 12:39:21 AM

Post# of 177496
I am not sure if you asking a question or if you are answering your own question. I was pointing out previous posts that Class III devices have been approved as Class II devices in the past. There are many posts from the past stating that there have been several similar therapies approved. Hence the de novo application. I guess why would the FDA request resubmission from ADMD.
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