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Business Update
Company provides update on Myopore Rx steroid lead status with FDA
February 20th, 2005
Enpath Medical, Inc., (NPTH) reported the U.S. Food and Drug Administration (FDA) has requested more clinical data regarding the company's Myopore Rx steroid lead before the agency will consider the company's request for marketing clearance. The company originally filed the submission in July 2004 and had been proceeding on the understanding that the FDA would grant approval based upon the originally determined regulatory pathway of a paper premarket approval (PMA) - a less burdensome approach that does not include prospective human clinical data. Jim Hartman, chairman and CEO of Enpath Medical, stated, "The FDA has informed us that they could not...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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