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Technology / Medical device / Lyodura / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Dura mater / Quality management system / Design controls / Creutzfeldt–Jakob disease / Medicine / Food and Drug Administration / Health


Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Human Dura Mater Document issued on: December 18, 2003 The draft of this document was issued on October 22, 2002. This document supersedes
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Document Date: 2003-12-17 09:19:01


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File Size: 63,87 KB

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Country

Germany / Japan / United States / /

Currency

pence / /

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Event

Product Issues / Product Recall / /

IndustryTerm

human dura mater devices / dura mater devices / human cellular and tissue-based products / cleared devices / human dura mater device / marketed devices / subject device / dura mater substitute devices / touch-tone telephone / to any device / research/investigationaluse tool / cellular and tissue-based products / /

MedicalCondition

HIV / neurologic disease / hepatitis C / hepatitis B / invariably fatal degenerative disease / hepatitis infection / CreutzfeldtJakob Disease / neurological and infectious diseases / Variant Creutzfeldt-Jakob Disease / CJD / Creutzfeldt Jakob Disease / variant CJD / nationwide CJD / Infection / progressive dementia / infectious disease / /

MedicalTreatment

brain surgery / neurosurgery / /

Organization

U.S. Department of Health and Human Services / World Health Organization / Food and Drug Administration / Center for Disease Control / Neurological Devices Advisory Panel / Surgery Devices Branch Division of General / Food and Drug Administration Center for Devices and Radiological Health Plastic / Neurological Devices office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Comments / FDA / FDA Transmissible Spongiform Encephalopathies Advisory Committee / Japanese Health and Welfare Ministry / /

Person

Charles Durfor / Restorative / /

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Position

Governor / treating physician / treating neurosurgeon / /

Product

human dura mater devices / /

Technology

antibodies / neurosurgery / /

URL

http /

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