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Clinical research / Pharmaceutical industry / Pharmacology / Implants / Breast implant / Premarket approval / Breast augmentation / Medical device / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]NewIHampshire Avenue
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Document Date: 2013-12-06 12:12:38


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City

Rockville / Santa Barbara / /

Company

Sientra Inc. / HP / /

Country

United States / Brazil / /

Currency

pence / /

Event

FDA Phase / Product Recall / Product Issues / /

IndustryTerm

Internet HomePage / similar device / comparison / device accounting / studies protocol / malfunctioned and such device / diagnostic devices / /

MedicalCondition

congenital deformities / lymphoma / connective tissue diseases / serious injury / breast cancer / cancer / rheumatologic and neurologic signs / cervicalivulvar cancer / rare disease / rare connective tissue diseases / brain cancer / infection / neurological diseases / /

MedicalTreatment

breast reconstruction surgery / breast implants / surgery / breast implant / Breast reconstruction / breast augmentation surgery / Breast augmentation / /

Organization

Food and Drug Administration / Surgical / Orthopedic and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / Center for Devices / Radiological Health PMA Document Mail Center / Center for Devices and Radiological Health / Radiological Health / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Center for Devices and Radiological Health DEPARTMENT OF HEALTH / US PAS / Restorative Devices Office / /

Person

Mark N. Melkerson / David Krause / /

/

Position

MP / physician / annual physician / RAC VP / Regulatory Affairs and Quality Assurance / /

Product

FDA / I1 / Silicone Gel / Silicone / PMA supplement / P070004 / /

ProvinceOrState

Maryland / California / /

PublishedMedium

the Post / /

Technology

MRI / cancer detection / studies protocol / /

URL

www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm / http /

SocialTag