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This article was originally published in The Gray Sheet

Executive Summary

HEALTHDYNE'S TRANQUILITY MP*R CPAP SYSTEM CHANGES REQUIRE 510(k) CLEARANCE, FDA says in a June 29 warning letter. The agency says that its review of promotional and labeling material for the continuous positive airway pressure system revealed "significant changes affecting the safety and efficacy of the device." FDA points out several significant changes that were made to the device since the original 510(k) was cleared in 1989. The modifications include, "but are not limited to, addition of microprocessor control, pressure control system changes, external phone line control, and the addition of a remote control." The agency also cites an addition to labeling, not cleared under the original 510(k), which states that the monitor "represents a significant advance in the technology used in the treatment of obstructive sleep apnea syndrome." After discussions with the agency, Healthdyne says it submitted a response to the warning letter the week of July 12. Healthdyne believes that the warning letter was the result of a "misunderstanding" between the company and FDA and that a new 510(k) will not be necessary for the device. According to the company, not all changes cited by FDA were actually made. For example, the firm says that a remote control was not added to the device. Healthdyne says that four minor modifications have been made to the device since 510(k) clearance, none of which the firm feels warrant a new 510(k). The modifications included: a change in the location of the pressure gauge ** addition of an on/off switch for user convenience ** modification of the overall shape of the device ** and a name change from Tranquility to Tranquility MPr for marketing purposes.

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