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We are not proposing any revisions to existing 411.362(c)(4)(ii)(A), which requires that an expansion exception request must include the name, address, National Provider Identification number(s) (NPI), Tax Identification Number(s) (TIN), and CMS Certification Number(s) (CCN) of the hospital requesting the expansion exception

The bottle was sealed with a butyl rubber stopper, and the headspace was purged with a nitrogen/carbon dioxide mixture (90:10)

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This mechanism endows P-Exos with the ability to deliver active coagulation factors deep into the pulmonary capillary bed, thereby driving widespread microthrombosis and ventilation/perfusion mismatch