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Health / Medical device / Premarket approval / Center for Devices and Radiological Health / Federal Food / Drug / and Cosmetic Act / Unique Device Identification / Adverse event / Title 21 of the Code of Federal Regulations / 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: 2015-01-16 15:53:46

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File Size: 36,98 KB

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City

Rockville / /

Company

AEs / Enteromedics Inc. / MPH / /

Country

United States / /

Currency

pence / /

Event

FDA Phase / Product Issues / Product Recall / /

Facility

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

IndustryTerm

subject device / Internet HomePage / similar device / malfunctioned and such device / therapy algorithm / diagnostic devices / treatment of diabetes / /

MarketIndex

Body Mass / /

MedicalCondition

hypertension / dyslipidemia / diabetes / serious injury / obesity / /

Organization

Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health PMA Document Control Center / office of Device Evaluation / Radiological Health / office of Surveillance and Biometrics / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Center for Devices / /

Person

Katherine Tweden implant / Maestro / Katherine Tweden / Silver Spring / William H. Maisel / Elizabeth Katz / /

/

Position

Director / Vice President / physician / Deputy Center Director / /

Product

approval of the PMA / Maestro® Rechargeable System / Maestro / WO66-G609 / PMA supplement / /

ProvinceOrState

Minnesota / Maryland / /

Technology

therapy algorithm / MRI / /

URL

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070974 / www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm / www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances / www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm / www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274 / http /

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