Consumer Information on: PROGENSA® PCA3 Assay

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Guidance for Industry and Food and Drug Administration Staff

Document issued on: March 9, 2012 For questions regarding this document contact Steven Gitterman at 301-796-6694 or by email at [email protected].   U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostic Device Evaluation and Safety Division of Microbiology Devices Preface Public Comment…

Consumer Information on: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity)

  This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Resolute MicroTrac Zotarolimus-Eluting Coronary…