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Puritan Bennett PB335 ventilator tracking exemption sought by company.

This article was originally published in The Gray Sheet

Executive Summary

PURITAN BENNETT PB335 VENTILATOR EXEMPTION FROM TRACKING is warranted because the respiratory system "is not a life-supporting or life-sustaining device," the company says in an April 12 citizens petition to FDA. PB asks the agency to revise its Feb. 9 clearance letter for the PB335 by deleting a statement that the system is subject to tracking requirements.
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