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Eight devices get 515(i) data deadline changed to Feb. 14, 1998.

This article was originally published in The Gray Sheet

Executive Summary

FOUR CARDIOPULMONARY DEVICES TO RECEIVE EXTENSION OF 515(i) deadline for submission of safety and effectiveness data from August 14, 1997 to February 14, 1998. The four devices -- sorbent hemoperfusion system, artificial embolization device, cardiopulmonary bypass arterial line blood filter and cardiopulmonary bypass oxygenator -- are among eight products for which FDA is modifying the deadline for the submission of device information under section 515(i) of the Food, Drug and Cosmetic Act to Feb. 14, 1998. The agency is preparing a Federal Register notice announcing the changed deadlines.

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