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We received one comment indicating that adopting a range would be more burdensome than encoding the exact amount and are thus finalizing that hospitals must encode the count of allowed amounts

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The applicant asserted that the Axoguard HA+ Nerve Protector TM differs in both composition and clinical context, as it is a biological matrix implant (not just a synthetic or biochemical barrier), which is used in peripheral nerve surgeries of the limbs, not in the spine

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The brand's published materials reference a clinical study (Sost MM et al., Nutrients, 2021) showing that MicrobiomeX intake was associated with shifts in the microbiome toward butyrate-producing bacterial populations