Penumbra: Emails with FDA Raise Questions About CEO’s Public Statements Regarding Adequacy of Warning to Doctors

Published on Aug 23, 2021

Emails between the Food and Drug Administration and Penumbra (PEN) last year show that the government had concerns regarding how the company was informing doctors of the risks related to the use of its Jet 7 Xtra Flex catheter, which at that point had been involved in the death of at least 14 stroke patients. […]

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