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Cardiac Pacemakers Inc.

This article was originally published in The Gray Sheet

Executive Summary

Receives approvable letter from FDA for its Endotak transvenous lead system, according to a July 26 CPI press release. The less-invasive device allows defibrillators to be connected to the heart without a thoracotomy, an open-chest procedure. The Lilly subsidiary says the "letter asks for some additional information and details changes the FDA is requesting in the labeling." CPI says it is evaluating the letter and formulating a response. FDA's circulatory system devices panel unanimously recommended approval of the lead system in April ("The Gray Sheet" April 19, p. 3).

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