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melody432

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melody432

Re: Fmello post# 6825

Wednesday, 04/07/2021 2:42:09 AM

Wednesday, April 07, 2021 2:42:09 AM

Post# of 7486
This was applied for under a PMA with FDA guidance. Once it's filed the FDA will either approve it based on the data given or will require further data. Up to the FDA. The application is greatly derisked by having an approved product that does fundamentally the same thing, replace damaged skin with new skin.
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