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Health / Premarket approval / Center for Devices and Radiological Health / Medical device / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Adverse event / Intraocular lens / Unique Device Identification / Food and Drug Administration / Medicine / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heath Service Foodwnd Dru Administration[removed]New Hampshire Avenue Document Control Room -WO66-G609
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Document Date: 2013-12-06 12:10:58

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File Size: 201,49 KB

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City

Rockville / Santa Ana / /

Currency

pence / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / /

MedicalCondition

serious injury / cataract / /

MedicalTreatment

surgery / cataract surgery / /

Organization

Division of Ophthalmic / Neurological / and Ear / Radiological Health PMA Document Mail Center / Device Evaluation Center for Devices and Radiological Health Ll / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Public Heath Service Foodwnd Dru Administration / Ear / Nose and Throat Devices Office / Center for Devices / /

Person

Evelyn De La Vega / B. Eydelman / Silver Spring / /

/

Position

Manager / Regulatory Affairs Abbott / Director / /

ProvinceOrState

Maryland / California / /

Technology

approved protocol / /

URL

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

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