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Article: Mark Adams, M.D.(BIMO)(Clinical report)
- Article from:
- Warning Letter Bulletin
- Article date:
- February 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Saginaw, MI, Jan. 23 (CDRH)
FDA conducted an inspection at this clinical site Oct. 11-18 to determine whether activities and procedures related to Adams' participation in the clinical study, "A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease," complied with applicable federal regulations. The inspection was conducted under a program designed to ensure that data and information contained in requests for IDES, PMA applications, and 510(k)s are scientifically valid and accurate, and to ensure that human subjects are protected from undue hazard or risk during the course of scientific ...
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