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PHYSIO-CONTROL LIFEPAK 300 PRODUCTION LINE REINSPECTION

This article was originally published in The Gray Sheet

Executive Summary

PHYSIO-CONTROL LIFEPAK 300 PRODUCTION LINE REINSPECTION is scheduled for the week of Jan. 3, according to FDA staffers. Physio-Control is not estimating when it will resume distribution of the Lifepak 300 but expects the FDA inspection of production lines to last from one to three weeks. The company also expects it will have to respond to FDA follow-up questions after the inspection.

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