LYCOS RETRIEVER 
Listing
built 643 days ago
"Listing on the Nasdaq is an important milestone for Medivation because Nasdaq is the largest screen-based electronic stock market in the U.S.," said David Hung, M.D., president and chief executive officer of Medivation. "We believe this is a significant step in Medivation's growth that reflects our financial and clinical accomplishments to date."
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Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.
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This section of the Listing of Impairments contains medical criteria that apply to adults age 18 and over. The medical criteria in Part A may ... be applied in evaluating impairments in persons under age 18 if the disease processes have a similar effect on adults and younger persons.
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There is no fee for device listing. However, many estabishments are subject to a registration fee. You must submit device listing information at the same time as the annual establishment registration requirement, October 1 to December 31 of each year.
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