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Health / Center for Devices and Radiological Health / Premarket approval / Unique Device Identification / Medical device / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Adverse event / Investigational Device Exemption / 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: 2015-03-03 15:35:30

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File Size: 71,43 KB

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City

Rockville / Morrisville / /

Company

Covidien LLC / /

Currency

pence / /

/

Event

FDA Phase / /

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 / /

MedicalCondition

serious injury / /

MedicalTreatment

embolization / /

Organization

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

Person

Bram D. Zuckerman / Silver Spring / Kenneth J. Cavanaugh / Kristine Canavan / Misti Malone / /

/

Position

Governor / Director / Vice President / Regulatory and Quality / M.D. Director / /

Product

PMA supplement / /

ProvinceOrState

Maryland / North Carolina / /

Technology

ultrasound / DUS / approved protocol / /

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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