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FY 2010 OSEL Annual Report
Table of Contents Preface Regulatory Support Activities Office of Science and Engineering Laboratories 2010 Highlights Division Descriptions Active Materials Biomechanisms Biophysics Electromagnetic and Wireless Technologies Emerging Biosensors and Biotechnology Fluid Dynamics Image Analysis Imaging Physics Infection Control Materials Performance Laboratory Medical Electronics Laboratory Optical Diagnostic Devices Laboratory Optical Therapeutics and Medical Nanophotonics Laboratory Software Laboratory…
Boston Scientific Innova Self-Expanding Stent System: Recall
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Orange Book Current Cumulative Supplement
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Summary Information for: Solesta®
Issued May 27, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated June 15, 2011
Consumer Information on: Solesta®
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: Solesta®Manufacturer: Oceana Therapeutics, Inc.Address: 2035…
Chantix (varenicline): Label Change
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Summary Information for: Pinnacle® CoMplete® Acetabular Hip System
Issued June 13, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated June 15, 2011
Consumer Information on: Pinnacle® CoMplete® Acetabular Hip System
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Class I Medical Device Recall: Boston Scientific Innova Self-Expanding Stent System
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