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Health / Investigational Device Exemption / Medical device / Premarket approval / Lamotrigine / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Medicine / Food and Drug Administration / Technology


[removed]Federal Register / Vol. 75, No[removed]Friday, August 6, [removed]Notices simultaneously reviewing a 510(k) or PMA. One example is when a
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City

Rockville / /

Country

United States / /

Currency

USD / /

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IndustryTerm

electronic applications / cleared device / orphan products / submitted applications / Web site addresses / /

MedicalCondition

orphan disease / rare diseases / rare disease / /

Movie

D. II / /

Organization

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / American Association of Clinical Chemists / office of Acquisitions & Grant Services / Center for Devices and Radiological Health / Division of Dockets Management / Availability AGENCY / FDA’s OPD / FDA / Division of Acquisition Support and Grants / FDA’s office of Orphan Products Development / Division of Small Manufacturers / International / and Consumer Assistance / Department of Health and Human Services / Bureau of Labor Statistics / With Electronic Research Administration / /

Person

Silver Spring / Leslie Kux / Vieda Hubbard / /

Position

Governor / Central Contractor / Acting Assistant Commissioner for Policy / Representative / /

Product

Lamotrigine / Zonisamide / /

ProvinceOrState

Maryland / /

Technology

http / /

URL

http /

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