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Implants / Prosthetics / Medical technology / Breast implant / Breast augmentation / Capsular contracture / Breast reconstruction / Silicone / Medical device / Medicine / Breast surgery / Breast


Summary Basis of Decision Inamed Silicone-Filled Breast Implants: Smooth Shell with Barrier Layer, Textured Shell with Barrier Layer
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Document Date: 2013-07-12 14:26:18

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File Size: 232,20 KB

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Company

Health Canada Inamed Corporation / BARRIER LAYER Inamed Corporation / FOREWORD Health Canada / Inamed Corporation / Barrier Layer Manufacturer Inamed Corporation / /

Country

United States / Canada / /

Event

FDA Phase / /

IndustryTerm

historic and current devices / final product / Heavy metal determinations / chemical extraction analysis / identical chemical compositions / chemical composition / smooth devices / study protocol / Subsequent applications / implantable devices / particular product / manufacturing / rubber / combination products / chemical analysis / manufacturing processes / food / manufacturing process / /

MedicalCondition

capsular contracture / cancer / infection / /

MedicalTreatment

breast implant / Breast reconstruction / breast reconstruction surgery / non-surgical treatment / Breast implant surgery / Breast implants / breast augmentation surgery / surgery / mastectomy / breast augmentation / /

Organization

Health Products and Food Branch / US Food and Drug Administration / European Union / Expert Advisory Panel / /

Product

SBD / /

PublishedMedium

Analytical Chemistry / the Health Canada review / /

Technology

study protocol / spectroscopy / /

URL

http /

SocialTag