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Re: None

Tuesday, 03/13/2018 12:11:39 PM

Tuesday, March 13, 2018 12:11:39 PM

Post# of 10345
Thirdly, to whoever posted that once this is approved,(that in itself is a bold statement) physicians could go ahead and use AC5 for internal applications, at their discretion. That is NUTS. The FDA would pull their clearance if this was even suggested. You must be thinking of off-label use of medications. Not the same with medical devices. Sorry. Norchi has clearly stated that a PMA (another couple of years out) would be needed for internal use.