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Oral surgery / Glycosaminoglycans / Pharmaceutical industry / Lip enhancement / Restylane / Hyaluronan / Medicis Pharmaceutical / Clinical trial / Investigational Device Exemption / Medicine / Plastic surgery / Oral and maxillofacial surgery


Restylane Injectable Gel (P040024/S051): Executive Summary
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City

Study / /

Company

ABBREVIATIONS AE / Medicis Global Services Corporation / Medicis Pharmaceutical Corporation / ITT / /

Country

Liechtenstein / United States / Iceland / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

assessment tool / chemical / /

MedicalCondition

xenogeneic disease / /

MedicalTreatment

Restylane / /

Organization

FDA / Radiological Health office of Device Evaluation General / European Union / Device Evaluation General and Plastic Devices Panel Public Advisory Committee / Food and Drug Administration / Center for Devices and Radiological Health / office of Device Evaluation Premarket Approval Application Per Protocol Statistical Analysis System Serious Adverse Event Treatment Emergent Adverse Event / office of Device Evaluation / Food and Drug Administration Center for Devices / Center for Devices and Radiological Health Case Report Form Clinical Study Report Food and Drug Administration Global Aesthetic Improvement Scale Investigator Brochure Investigational Device Exemption Independent Photographic Reviewer Intent-to-Treat Medical Dictionary for Regulatory Activities / /

Person

Blinded Evaluator / /

Position

physician / Treating Investigator / Evaluator / /

Product

Restylane / G060011 / P020023 / Treatment / /

ProgrammingLanguage

Hoc / /

PublishedMedium

Baseline / /

SocialTag