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Clarification

This article was originally published in The Gray Sheet

Executive Summary

Philips Healthcare clarifies that it has complied with FDA's Aug. 7 deadline for submitting safety and efficacy data for currently marketed pre-amendment device types. Philips markets the HeartStart home defibrillator and Q-CPR external compression device, which are both pre-amendment Class III devices cleared via 510(k). The data was submitted the week of Aug. 3, the company says, although it initially reported the week of Aug. 10 that it was still preparing its response (1"The Gray Sheet" Aug. 17, 2009)

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