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The real human data belong to different molecules/uses

Product Specifications Composition: Sterile water with 0.9% benzyl alcohol Appearance: Clear, colorless solution Preservative Content: 0.9% benzyl alcohol Sterility: Filtered and prepared under controlled conditions Storage: Store at controlled room temperature

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Sterile Bacteriostatic Water: Recommended for in vivo rodent model preparations requiring multi-dose stability

As we stated in the CY 2021 OPPS final rule with comment period (85 FR 85947), we believe that similar resources and device costs are involved with the Corvia Medical interatrial shunt procedure and the V-Wave interatrial shunt procedure

Although SwissChems labeled these products for research purposes only, the FDA considered them intended for human consumption