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Previous Volume 359:2610 December 11, 2008 Number 24 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: In their Perspective article in this issue of the Journal, Hauser and Almquist¹ discuss issues involved in the testing of implantable cardioverter–defibrillators (ICDs). The authors contend that "the decision by the FDA [Food and Drug Administration] and industry to forgo premarketing clinical testing of the [new quadripolar,² or IS-4] connector is not in the best interest of patients." This is an incorrect description of the position of the FDA.

The FDA has made no absolute decision that all implantable leads with IS-4 connectors will not require new clinical data. When we are evaluating an application for a . . . [Full Text of this Article]

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