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Re: trusttheman post# 9872

Saturday, 07/16/2022 7:32:30 PM

Saturday, July 16, 2022 7:32:30 PM

Post# of 13869
I agree, “mislead”applies more to the PRs. I suppose better wording in regards to FDA would be- don’t underestimate the level of scrutiny the PMA is exposed to. (Don’t cut corners)
Hemostyp is a superior product to Surgicel and under the right guidance it will be a Class 3 gauze.
But PMAs can die on the vine if not managed properly. They will then have to restart the process.
Again, this product will be Approved at some point. I would prefer if it was on this go around.