ReGen maintains timeline guidance for collagen scaffold device in 510(K) submission

By Lisa Kerner

Erie, Pa., April 28 - ReGen Biologics, Inc. responded to a request from the Food and Drug Administration for additional information regarding the company's 510(k) submission for its collagen scaffold device.

"We submitted the 510(k) on December 28, 2005 and our guidance relating to the 510(k) indicated that we expected a timeline of six to nine months before a decision from the FDA," chairman and chief executive officer Gerald E. Bisbee Jr. said in a company news release.

"We are currently responding to a request for additional information from the FDA and our timeline guidance has not changed."

ReGen is an orthopedic products company located in Franklin Lakes, N.J., that develops tissue growth and repair products.

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