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Summary Information for: MEL 80? Excimer Laser System
Issued March 28, 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 April 25, 2011
Guidance for Industry and FDA Staff
Document issued on: April 25, 2011 The draft of this document was issued April 6, 2006 For questions regarding this guidance document, contact Charles Durfor, Ph.D., at 301-796-6438 or by email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Plastic and Reconstructive Surgery Devices BranchDivision of…
FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [04-22-2011] The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn’s disease. The…
Tysabri (natalizumab): Update of Healthcare Professional Information
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Summary Information for: Valiant® Thoracic Stent Graft with the Captiva Delivery System
Issued April 1, 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 April 20, 2011
FDA Drug Info Rounds
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Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
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Consumer Information on: Valiant® Thoracic Stent Graft with the Captiva Delivery System
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Consumer Information on: Pipeline? Embolization Device
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