DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
July 26, 2005
OUR STN: BL 103898/5019
Medion Diagnostics GmbH
ATTN: Mr. Michael Campbell
Olympus America Inc.
3131 West Royal Lane
Irving, TX 75063-3104
Dear Mr. Campbell:
We have approved your request (submitted on behalf of Medion Diagnostics GmbH (Medion), U.S. license 1616) to supplement their biologics license application for Reagent Red Blood Cells to include modification to the manufacturing process and creation of new Reverse-Cyte A1 and B cells and Search-Cyte Pool, Duo and Trio Reagent Red Blood Cell products for use on the TANGO Automated Blood Bank Analyzer.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in Medion's biologics license application file.
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Alan E. Williams, Ph.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research