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Health / Pharmaceutical industry / Clinical research / Food law / Pharmaceuticals policy / Center for Devices and Radiological Health / Medical device / Premarket approval / Unique Device Identification / Food and Drug Administration / Medicine / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-12-30 12:09:38

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File Size: 48,94 KB

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City

Salt Lake City / Rockville / /

Company

Myriad Genetic Laboratories / In Vitro Diagnostics / Jolette Franco Regulatory Affairs Manager Myriad Genetic Laboratories Inc. / /

Currency

pence / /

Event

FDA Phase / Product Recall / Product Issues / /

Facility

Radiological Health PMA Document Control Center / New Hampshire Avenue Document Control Center / /

IndustryTerm

subject device / Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / diagnostic device / laboratory site / /

MedicalCondition

ovarian cancer / serious injury / /

Organization

Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health PMA Document Control Center / Director Office / Radiological Health / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Center for Devices / /

Person

Silver Spring / Franco / Alberto Gutierrez / Eunice Lee / /

/

Product

approval of the PMA / approval of a PMA / WO66-G609 / BRACAnalysis CDx™ / PMA supplement / /

ProvinceOrState

Utah / Maryland / /

URL

www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm / www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274.h / www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/P / www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm / http /

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