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Glycosaminoglycans / ArteFill / Oral and maxillofacial surgery / Oral surgery / Juvéderm / Restylane / Sculptra / Wrinkle / Hyaluronan / Medicine / Surgery / Plastic surgery


Executive Summary Dermal Filler Devices Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation
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Document Date: 2008-11-14 08:41:41

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File Size: 167,09 KB

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Company

Perlane Injectable Gel Medicis Aesthetics Holdings Inc. / Poly(L-lactic acid) Sculptra Sanofi Aventis Pharmaceuticals Inc. / Allergan / HIV Poly(methyl methacrylate) ArteFill Artes Medical USA Inc. / Sculptra* Perlane (Sanofi Aventis (Medicis Pharmaceutical) Aesthetics Holdings / Reconstructive Devices Branch / Hydroxylapatite Radiesse Bioform Medical Inc. / Genzyme / Sculptra Sanofi Aventis Pharmaceuticals / Inc. / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

dermal filler devices / water-based carrier gel / filler devices / dermal filler device / premarket applications / gel carrier / dermal filler products / /

MedicalCondition

HIV / pain / Injuries / /

MedicalTreatment

Restylane / /

Organization

Advisory Panel Executive Secretary office of Device Evaluation Division / Public Advisory Committee / Radiological Health office of Device Evaluation General / Nasrin Mirsaidi office of Surveillance / Food and Drug Administration Center for Devices / FDA / Azadeh Shoaibi office of Surveillance / Surveillance and Biometrics Division / office of Device Evaluation Division / /

Person

Azadeh Shoaibi / Lisa M. Lim / Component Poly(methyl / Nasrin Mirsaidi / Component Poly / Jacqueline Francis / Jiyoung M. Dang / D. Charles N. Durfor / /

Position

Major / representative / General / /

Product

sodium chloride / lidocaine / sterile water for injection / Sterile Water / Restylane Injectable Gel / Radiesse / P030032 / P030050 / /

Technology

33 Study Protocol / alpha / /

URL

http /

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