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Implants / Breast / Breast implant / Plastic surgery / Breast augmentation / Silicone / Breast reconstruction / Tissue expansion / Capsular contracture / Medicine / Breast surgery / Prosthetics


Guidance for Industry and FDA Staff Saline, Silicone Gel, and Alternative Breast Implants Document issued on: November 17, 2006 This document supersedes “Guidance for Saline, Silicone Gel, and Alternative
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Company

Cox / /

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Event

FDA Phase / /

Facility

Laboratory Analyses/Testing / /

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IndustryTerm

chemical crosslinking / silicone rubber shell / post-amendment devices / product development protocols / connector systems / chemical name / basic device / silicone rubber / final device / chemical/material / manufacturing / chemical analyses / chemical / chemicals / clinical protocols / manufacturing process / /

MedicalCondition

cancer / sterility / Assessment - Connective Tissue Diseases / /

MedicalTreatment

clinical protocols / breast implant / breast reconstruction / breast reconstruction surgery / breast implants / breast augmentation surgery / surgery / breast augmentation / Plastic and Reconstructive Surgery / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration / Food and Drug Administration Center for Devices and Radiological Health Plastic / Division of Dockets Management / FDA / Reconstructive Surgery Devices Branch Division of General / Neurological Devices office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Written / /

Person

Nada Hanafi / Restorative / /

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Position

Governor / Physician / surgeon / General / General Information For / /

Product

Silicone gel / /

Technology

product development protocols / /

URL

http /

SocialTag